SlideShare a Scribd company logo
Your Complete Quality Solution Provider
for the Life Science Industry
We are a ISO 9001 certified technology solutions and compliance
consulting services company with global capabilities deliverable
throughout the entire product quality life cycle, allowing us to
offer services at a very competitive price.
PQE at-a-glanceWHO IS PQE?
• Quality and Compliance Solutions Provider – Complete Quality Solution Provider for our Customer’s GCP, GLP, GMP & GDP product
	 development challenges since 1998.
• Hundreds of compliance solutions consultants on staff, enabling rapid global deployment of flexible, well-organized project teams anywhere
	 our clients require
• Wide geographical coverage - offices throughout Europe and North and South America, the Middle East,
India and China.
• International references thousands projects completed worldwide.
• Experts fluent in more than 20 languages.
• Experience in working on regional/global projects and rollouts for large corporations.
• Long history of supporting local leaders and small/medium companies in reaching
FDA / EMA / ANVISA / WHO and other international, regional and local regulatory
compliance authorities .
• Proven methodology along with effective knowledge transfer mechanisms.
• Exceptional focus on cost effectiveness, while maintaining the highest quality standards.
• Internal instruments warehouse with “project ready” equipment validation & utilities
qualification instrumentation with traceable calibration certificates.
WHY PQE?
Our broad services portfolio, extensive experience,
effective project management, and exceptional cost effec-
tiveness, have already proven to be a winning combination
for global corporations, as well as small and medium sized
companies.
PQE / CORE BUSINESS
Since the foundation of PQE, I have strongly believed that our core values, know-how, people and ethics, can make PQE the market leader
for sustainable compliance solutions in Europe and beyond. As a matter of fact, we are growing year by year thanks to a full time workforce
of dedicated employees, which allows us to enhance our robust and standardized commitment to excellence. Our passion for the growth and
development of life science companies enables PQE to consistently exceed our customer’s expectations. This is the reason why we have suc-
cessfully completed thousands of projects around the world, working in more than 20 different languages. Come discover what our customers
have experienced.
PQE: Your Partners in Excellence
Gilda D’Incerti, CEO
Data Integrity Assurance
Global leader in full product life cycle computer system validation
and IT compliance.
Qualification & Engineering
Your reliable partner for GMP Review, Facility Design, Qualification
and Commissioning Activities.
Regulatory Affairs
A full service provider supporting companies through the entire
regulatory lifecycle
Compliance
Leading global services for cGxP compliance needs.
Data Integrity Data integrity may expose life science companies to significant regulatory and business risk.
PQE’s multidisciplinary teams allow customers to achieve compliance and the Data Governance
System, which is integral to a fully functional Quality System.
The integrity of regulated data relies upon the validation of the computer system responsible
for managing regulated data. As a proven global leader on this topic, PQE can support
customers in the implementation of a cost effective and feasible validation strategy.This results
in the assurance of the systems validation life cycle, which in turn enhances and improves
product quality, patient safety and data integrity. PQE’s integrated approach enables client’s
data integrity assurance and validation requirements through a scalable and fully regulatory
compliant delivery model, based on a robust risk analysis.
DATA INTEGRITY ASSURANCE
•	 Data Integrity Policy
•	 Computer Validation Strategy
•	 Best Practices for Cost Saving & Quality of
21 CFR Part 11 compliance strategy
•	 Validation Templates and System-specific
Packages
•	 21 CFR Part 11 & EU GMP Annex 11 As-
sessments
•	 Risk-prioritized & Turnkey Remediation
projects
•	 21 CFR Part 11 Inspection Readiness pro-
jects
•	 Data Integrity Historical Verification
•	 Continuous Monitoring procedures for
Data Integrity
•	 Audit Trail Review Methodologies
Capabilities:
DATA INTEGRITY ASSURANCE
Computer System
Validation
Computer System Validation has been PQE’s core business since its foundation in 1998. We
have an unmatched track record of providing our clients with strategy and execution support
with their FDA / EMA / WHO / TGA / SSA/ SFDA /ANVISA / INVIMA and other Local Regula-
tory Body compliance projects. Our multidisciplinary team, which has extensive years of expe-
rience, enables us to support our clients in turnkey validation projects for all types of compu­
terized systems: management information systems, systems from a manufacturing area and
applications used in Laboratories.
•	 Ongoing Adaptation of Risk based Compu-
ter Validation Approach to current Regula-
tory expectations
•	 Computer Validation of Global and Local IT
Systems (e.g. ERP, LIMS, MES)
•	 Laboratory Systems Validation
•	 Process Control Systems Validation
•	 CSV Best Practices
•	 Documentation Templates
•	 User Requirements and Process Mapping
•	 Data Migration Verification strategy and
execution
•	 System Testing (Unit & Integration Tests,
UAT)
•	 Validation Test Planning, Execution &
Documentation
•	 Best Practices Procedures to maintain
the Validated status
•	 Change Management
•	 Periodic Reviews
Capabilities:
Regulated
IT Solutions
Regulated IT Solutions consists of a multidisciplinary team of professionals with a background
in electronic engineering, software development, systems integration and information techno-
logy. We are able to offer a broad spectrum of scalable services, thanks to our proven expe-
rience in the field of IT solutions, infrastructure qualification and computer systems validation
for life science companies.
•	 Assessment of the compliance level of IT
processes against international standards
and guidelines (eg. GAMP, NIST, ITIL)
•	 IT Infrastructure Qualification
•	 IT Infrastructure design & implementation
project management
•	 Design and implementation of secure
WANs
•	 Selection and evaluation of hardware and
software suppliers
•	 Management and monitoring of system
integrator
•	 Design & management of server rooms
and networks
•	 Data housing and hosting services
•	 Data archiving and retrieval
•	 ERP suitability and gap analysis
•	 Security standard assessment
Capabilities:
DATA INTEGRITY ASSURANCE
Qualification
& Commissioning
Our service excellence is achieved through an interdisciplinary teamwork among engineers
and technicians, who have a unique integrated knowledge in process engineering, information
technology and quality in regulated environments.
Due to our complete in house instruments park and our robust expertise in Pharmaceutical,
Biopharmaceutical and APIs field, we can provide turnkey qualification solutions for process
equipment and utilities qualification, based on the latest technologies and regulatory require-
ments.This allows us to focus on minimizing compliance related risks and costs for our clients.
•	 Qualification protocols writing and execution
(Installation, Operational and Performance
Qualification)
•	 Validation Master Plan
•	 Commissioning Plan
•	 Cleaning Validation
•	 Process Validation
•	 Media Fill Protocols
•	 Calibration services
•	 Witnessing of Supplier Testing activities
(FAT/SAT support)
•	 Inventory of Process Equipment and Utilities
•	 Quality Risk Management
•	 User Requirement Specifications
•	 Technology Transfer
•	 Process Analytical Technology
(PAT) Support
•	 Clean Room Qualification
•	 Temperature Mapping Services
Capabilities:
QUALIFICATION & ENGINEERING
Facility Engineering There are many steps in the design of a pharmaceutical facility. In PQE’s approach and solu-
tions, we emphasize delivery based on our three key project principles: TIME - COST - QUA-
LITY.
Our goal is to establish a partnership with our clients in order to create cost- and business-
effective engineering solutions for Pharmaceutical, Biopharmaceutical, APIs and Medical De-
vices facilities and to ensure that related national and international regulatory requirements
are met.
Due to our focus on Life Science, we always assess and design with the latest standards and
with the point of view of the facilities end users.
•	 Concept Development
•	 Basic & Detail Design
•	 Technology Transfer Support
•	 Commissioning Support
•	 GMP Review
•	 Construction Supervision
•	 Project Management
•	 Visual Factory Programs
•	 Procurement Support
QUALIFICATION & ENGINEERING
Capabilities:
Regulated Laboratory
Solutions
PQE has multidisciplinary and specialized teams, which include engineers, chemists, biolo-
gists and IT experts. Our aim is to support laboratories in the food and drugs industries, with
independent and fully specialized services providing accurate and reliable analytical data in a
fully regulated environment.
•	 Data integrity and compliance
•	 Purchasing and project coordination for new
laboratories and renovation
•	 Process mapping and solutions for a paperless
lab
•	 Analytical instrument qualification
•	 Equipment calibration and maintenance plan
•	 Analytical computer system validation
•	 LIMS, Chromatography Data Software vendor
selection, support and validation
•	 Analytical method development and validation
•	 Stability studies
Capabilities:
QUALIFICATION & ENGINEERING
COMPLIANCE
GMP & GDP Compliance We want to be sure that we understand your needs, in order to support, protect and help you
thrive in all markets. Our aim is to help you be stronger and fitter. Our customized and cost-
effective solutions for Quality (beyond compliance) are a competitive advantage; as non-com-
pliance is an expense that no company can afford. PQE’s commitment is to help our customers
identify problems with a proactive attitude, before they arise; this commitment will guide you to
make your processes smarter and more efficient. Overall we will support you to find the most
sustainable way to develop practical and tailored plans that align global quality capabilities with
your business strategy.
Capabilities:
•	 Compliance Strategies
•	 Continuous improvement and performance
metrics implementation
•	 Risk Management implementation
•	 Quality system implementation (corporate
policies and local SOPs)
•	 Quality structures (QC, QA, RA) assess-
ments for skills and staffing
•	 Inspection readiness Master Plans (FDA,
EU, ANVISA, CFDA, PMDA, TGA etc)
•	 Mock Inspections
•	 Assistance during inspections/post-inspec-
tion
•	 Due diligence (Quality) of product and faci-
lity acquisitions
•	 Third party auditing
•	 Supplier management and monitoring stra-
tegies
•	 Training systems implementation
•	 Training in GMP/GDP compliance and to-
pical matters
•	 Mentoring/coaching
•	 Support in critical event management
(complaints, deviations, sterility/mediafill
failures, recalls)
•	 Change management support
•	 CAPA System Implementation
•	 Annual Product Review support
•	 Data Trending
GCP Compliance The development of a GCP Quality Management System (plan and resources) is the basis to
promote and support compliance, while minimizing regulatory risk. PQE proposes the imple-
mentation of a GCP quality strategy that will adapt to the Client’s requirements and support an
effective and compliant conduction of clinical trials.This monitoring process ensures adequate
protection of subjects, along with the quality and integrity of the clinical study data itself. In
order to deliver leading GCP services to PQE clients, our consultants practice the most inno-
vative Quality by Design and Quality Risk Management approaches related to clinical studies.
PQE ensures a strong emphasis on the concepts of good quality control, with adequate do-
cumentation throughout the delivery of a clinical trial by investigators and throughout all data
management processes leading to a regulatory submission.
Capabilities:
•	 Self-assessment of GCP Quality System
compliance against written standards (pro-
cess mapping and gap analysis)
•	 SOPs/Policies Development and admini­
stration
•	Audits:
	- CROs
	- eSystem providers
	- Centralized service providers (e.g. labo- 	
ratories, cardiac safety)
	- Clinical database
	- Study Documents
	- Trial Master File
•	 Site assessment (feasibility, compliance)
•	 Inspection readiness (Sponsor, CRO,
investigational site)
•	 Inspection support (back and war room)
•	 QA services and training
COMPLIANCE
PV Compliance In 2010, Regulatory Authorities raised the bar of compliance of the Pharmacovigilance
System and an increasing number of countries are now performing routine regulatory
inspections targeting Pharmacovigilance. An established quality system that is adequate and
effective for performing pharmacovigilance activities has become a regulatory requirement.
PQE can support the implementation of a pharmacovigilance quality system, starting from the
compliance assessment of “AS-IS” scenario, which involves document editing and the quality
system deployment at corporate or local level. The focus of PQE’s support is the compliance
with applicable regulation as well as the suitability of the system to the company needs.
Capabilities:
•	 Self-assessment of Pharmacovigilance
System compliance
•	 Editing of quality documents (Policies/
SOPs/Working Instructions)
•	 PSMF editing
•	 Cleaning of safety database
•	 SOPs review and deployment
•	 Compliance monitoring
•	 Preparation for Regulatory Inspection
•	 Post inspection Follow-up
•	 CAPA definition and implementation
•	 Development of Training Plan
•	 Pharmacovigilance Audits
•	 Qualification of PV service providers
•	 Data Migration Plan and Data Quality
Control
COMPLIANCE
Third Party Audits
•	 Manufacturers of API, Intermediates and
Excipients (APIC certified Auditors)
•	 Distributors of API
•	 Contract Laboratories (GMP/GLP)
•	 Manufacturers of Final Drug Forms
•	 Distributors and Logistic Providers (GDP)
•	 Software Suppliers (PDA and Tick-it certi-
fied Auditors)
•	 Contract Manufacturing Organisation
•	 Laboratory Testing
•	 Clinical & Pre-Clinic Audits
•	 Investigational Site Audit
•	 Sterilisation Facilities
•	 Storage and Distribution
•	 Suppliers of Equipment & Utilities
Based on recent developments in pharmaceu-
tical regulations, concerning starting materi-
als and suppliers, qualification has become
even more critical from the GxP perspective.
Furthermore, EU and FDA regulators have
emphasized that Third Party Audits are ac-
cepted. By utilizing its experience in the Life
Science sector, PQE supports manufacturers
in performing many kinds of audits, conduc-
ted worldwide by our lead auditors that have a
minimum of 15 years of field experience.
Capabilities: Learning Management
and Knowledge Transfer •	 Computer System Validation (GAMP,
21CFR Part 11, IT infrastructure)
•	 FDA Inspection Readiness
•	 Quality Management System
•	 Process Equipment Qualification
•	 Laboratory Equipment Qualification
•	 Process Validation
•	 Analytical Methods Validation
•	 Regulatory Affairs
•	 Risk Management
•	 GCP Compliance and Clinical Trials
•	 Process Analytical Technology
•	 Technology Transfer
•	 Pharmacovigilance
PQE offers cost effective practical training
courses based on latest industry guidance,
regulations and real life experience. All cour-
ses are full of examples, case studies, and
are held by our top class executive consul-
tants.
Courses can be organized both at funda-
mental and advanced levels based on the fol-
lowing topics:
Capabilities:
COMPLIANCE
REGULATORY AFFAIRS
Regulatory Affairs PQE supports customers through the entire drug regulatory lifecycle, providing a full range of
regulatory activities. Our service begins with the development of the regulatory strategy and
concludes with the editing, amendment and submission of the necessary documents of the
dossier.
Due to the expertise of our consultants, fully electronic submissions for the EU / USA, along
with paper submissions are handled in the fastest and most professional manner, while
ensuring that dossiers are compliant to the strictest regulations.
Capabilities:
•	 Regulatory Strategy for EU, USA, LATIN
AMERICA, CANADA and other countries
•	 Dossier gap analysis and review for Drug
Products and Drug Substances
•	 DMF / ASMF / CEP Dossiers preparation
in eCTD or NeeS format
•	 Preparation of Product Registration
	 Dossiers (Quality part)
•	 Country-specific Module 1
•	 Expert Reports, Overviews and
	Summaries
•	 Investigational Medicinal Product Dossiers
•	 Variation/Change application Dossiers
•	 Reformatting of documents to eCTD
compliant submissions
•	 Drug Listing
•	 Support for electronic submission
HEADQUARTERS
Località Prulli, n°103/C • 50066 Reggello • (FI) • Italy
Tel. +39 055 52 75 100 • Fax +39 055 52 75 142
www.pqe.eu • info@pqe.eu
Offices and Representatives
Brazil | China | Ecuador | Germany | India | Israel | Italy | Japan | Mexico | Spain | Switzerland | Turkey | United States
We support you globally while delivering locally

More Related Content

What's hot

MARK RESUME 021016
MARK RESUME 021016MARK RESUME 021016
MARK RESUME 021016
Mark Schulte
 
cv1
cv1cv1
SoftProdigy's Corporate Presentation
SoftProdigy's Corporate PresentationSoftProdigy's Corporate Presentation
SoftProdigy's Corporate Presentation
SoftProdigy - We know software!
 
Ivy - CV
Ivy - CVIvy - CV
Ivy - CV
Ivy Baquiran
 
Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...
Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...
Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...
Oracle
 
Advanced Testing Laboratory services presentation
Advanced Testing Laboratory services presentationAdvanced Testing Laboratory services presentation
Advanced Testing Laboratory services presentation
mikea888
 
SHIVANGI SINHA-CV 2016
SHIVANGI SINHA-CV 2016SHIVANGI SINHA-CV 2016
SHIVANGI SINHA-CV 2016
Shivangi Sinha
 
Resume bernadette yousif-sr. qa
Resume   bernadette yousif-sr. qaResume   bernadette yousif-sr. qa
Resume bernadette yousif-sr. qa
Bernadette Yousif
 
CNarcisse_resume
CNarcisse_resumeCNarcisse_resume
CNarcisse_resume
Cnarcsse01
 
Andrew Ritchie Resume
Andrew Ritchie ResumeAndrew Ritchie Resume
Andrew Ritchie Resume
Andrew Ritchie
 
Introduction to VEAPS your Industrial Automation and Integration Team
Introduction to VEAPS your Industrial Automation and Integration TeamIntroduction to VEAPS your Industrial Automation and Integration Team
Introduction to VEAPS your Industrial Automation and Integration Team
Tbrad
 
Quality harjeet gill 11 19_16
Quality harjeet gill 11 19_16Quality harjeet gill 11 19_16
Quality harjeet gill 11 19_16
Harjeet Gill
 
Donald_L_Loocke_Resume_TEr3
Donald_L_Loocke_Resume_TEr3Donald_L_Loocke_Resume_TEr3
Donald_L_Loocke_Resume_TEr3
dloocke
 
ADR Brochure
ADR  BrochureADR  Brochure
ADR Brochure
Pradeep M
 
Enhancing QA Strategy to Achieve Agile Quality Engineering
Enhancing QA Strategy to Achieve Agile Quality Engineering Enhancing QA Strategy to Achieve Agile Quality Engineering
Enhancing QA Strategy to Achieve Agile Quality Engineering
Aspire Systems
 
Mei Fung Curriculum Vitae_2016
Mei Fung Curriculum Vitae_2016Mei Fung Curriculum Vitae_2016
Mei Fung Curriculum Vitae_2016
Mei Fung Chong
 
AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...
AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...
AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...
Jeff Ondria
 
Shield Watch IT & Web Services - Company overview (2016)
Shield Watch IT & Web Services - Company overview (2016)Shield Watch IT & Web Services - Company overview (2016)
Shield Watch IT & Web Services - Company overview (2016)
Shield Watch IT & Web Services
 
Presentation
PresentationPresentation
Presentation
MichaelEnoma
 
Henry P. Agsaullo_Jr_Quality Professional
Henry P. Agsaullo_Jr_Quality ProfessionalHenry P. Agsaullo_Jr_Quality Professional
Henry P. Agsaullo_Jr_Quality Professional
HENRY JR AGSAULLO
 

What's hot (20)

MARK RESUME 021016
MARK RESUME 021016MARK RESUME 021016
MARK RESUME 021016
 
cv1
cv1cv1
cv1
 
SoftProdigy's Corporate Presentation
SoftProdigy's Corporate PresentationSoftProdigy's Corporate Presentation
SoftProdigy's Corporate Presentation
 
Ivy - CV
Ivy - CVIvy - CV
Ivy - CV
 
Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...
Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...
Symantec, Facebook and Navillus - a comprehensive approach to securing & moni...
 
Advanced Testing Laboratory services presentation
Advanced Testing Laboratory services presentationAdvanced Testing Laboratory services presentation
Advanced Testing Laboratory services presentation
 
SHIVANGI SINHA-CV 2016
SHIVANGI SINHA-CV 2016SHIVANGI SINHA-CV 2016
SHIVANGI SINHA-CV 2016
 
Resume bernadette yousif-sr. qa
Resume   bernadette yousif-sr. qaResume   bernadette yousif-sr. qa
Resume bernadette yousif-sr. qa
 
CNarcisse_resume
CNarcisse_resumeCNarcisse_resume
CNarcisse_resume
 
Andrew Ritchie Resume
Andrew Ritchie ResumeAndrew Ritchie Resume
Andrew Ritchie Resume
 
Introduction to VEAPS your Industrial Automation and Integration Team
Introduction to VEAPS your Industrial Automation and Integration TeamIntroduction to VEAPS your Industrial Automation and Integration Team
Introduction to VEAPS your Industrial Automation and Integration Team
 
Quality harjeet gill 11 19_16
Quality harjeet gill 11 19_16Quality harjeet gill 11 19_16
Quality harjeet gill 11 19_16
 
Donald_L_Loocke_Resume_TEr3
Donald_L_Loocke_Resume_TEr3Donald_L_Loocke_Resume_TEr3
Donald_L_Loocke_Resume_TEr3
 
ADR Brochure
ADR  BrochureADR  Brochure
ADR Brochure
 
Enhancing QA Strategy to Achieve Agile Quality Engineering
Enhancing QA Strategy to Achieve Agile Quality Engineering Enhancing QA Strategy to Achieve Agile Quality Engineering
Enhancing QA Strategy to Achieve Agile Quality Engineering
 
Mei Fung Curriculum Vitae_2016
Mei Fung Curriculum Vitae_2016Mei Fung Curriculum Vitae_2016
Mei Fung Curriculum Vitae_2016
 
AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...
AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...
AkzoNobel Specialty Chemicals Achieves a One-Plan Harmonized S&OP Process Wit...
 
Shield Watch IT & Web Services - Company overview (2016)
Shield Watch IT & Web Services - Company overview (2016)Shield Watch IT & Web Services - Company overview (2016)
Shield Watch IT & Web Services - Company overview (2016)
 
Presentation
PresentationPresentation
Presentation
 
Henry P. Agsaullo_Jr_Quality Professional
Henry P. Agsaullo_Jr_Quality ProfessionalHenry P. Agsaullo_Jr_Quality Professional
Henry P. Agsaullo_Jr_Quality Professional
 

Viewers also liked

Innovacyn_OWM_0515_lr
Innovacyn_OWM_0515_lrInnovacyn_OWM_0515_lr
Innovacyn_OWM_0515_lr
Sean McCormack
 
Published paper
Published paperPublished paper
Published paper
Vahid Nooraie
 
Conflict resolution techniques for adolescents june 15, 2015
Conflict resolution techniques for adolescents june 15, 2015Conflict resolution techniques for adolescents june 15, 2015
Conflict resolution techniques for adolescents june 15, 2015
hlumumb1
 
Fmcg stock and inflation by jayadev nair
Fmcg stock and inflation by jayadev nairFmcg stock and inflation by jayadev nair
Fmcg stock and inflation by jayadev nair
Jayadev Nair
 
Earth Stream Oil And Gas Presentation
Earth Stream Oil And Gas PresentationEarth Stream Oil And Gas Presentation
Earth Stream Oil And Gas Presentation
fourie_brand2012
 
Anti Dumping Case
Anti Dumping CaseAnti Dumping Case
Anti Dumping Case
dsaichandan
 
Soneto de Francisco de Quevedo
Soneto de Francisco de QuevedoSoneto de Francisco de Quevedo
Soneto de Francisco de Quevedo
Leslie Rosas
 
Mecanismos de acción hormonal
Mecanismos de acción hormonalMecanismos de acción hormonal
Mecanismos de acción hormonal
josemiguelvalleo
 
Understanding Financial Products
Understanding Financial ProductsUnderstanding Financial Products
Understanding Financial Products
Charu Rastogi
 
Mecanismos de acción hormonal: hormonas hidrosolubles
Mecanismos de acción hormonal: hormonas hidrosolublesMecanismos de acción hormonal: hormonas hidrosolubles
Mecanismos de acción hormonal: hormonas hidrosolubles
Hogar
 

Viewers also liked (10)

Innovacyn_OWM_0515_lr
Innovacyn_OWM_0515_lrInnovacyn_OWM_0515_lr
Innovacyn_OWM_0515_lr
 
Published paper
Published paperPublished paper
Published paper
 
Conflict resolution techniques for adolescents june 15, 2015
Conflict resolution techniques for adolescents june 15, 2015Conflict resolution techniques for adolescents june 15, 2015
Conflict resolution techniques for adolescents june 15, 2015
 
Fmcg stock and inflation by jayadev nair
Fmcg stock and inflation by jayadev nairFmcg stock and inflation by jayadev nair
Fmcg stock and inflation by jayadev nair
 
Earth Stream Oil And Gas Presentation
Earth Stream Oil And Gas PresentationEarth Stream Oil And Gas Presentation
Earth Stream Oil And Gas Presentation
 
Anti Dumping Case
Anti Dumping CaseAnti Dumping Case
Anti Dumping Case
 
Soneto de Francisco de Quevedo
Soneto de Francisco de QuevedoSoneto de Francisco de Quevedo
Soneto de Francisco de Quevedo
 
Mecanismos de acción hormonal
Mecanismos de acción hormonalMecanismos de acción hormonal
Mecanismos de acción hormonal
 
Understanding Financial Products
Understanding Financial ProductsUnderstanding Financial Products
Understanding Financial Products
 
Mecanismos de acción hormonal: hormonas hidrosolubles
Mecanismos de acción hormonal: hormonas hidrosolublesMecanismos de acción hormonal: hormonas hidrosolubles
Mecanismos de acción hormonal: hormonas hidrosolubles
 

Similar to Pqe brochure ph_english_june_2016

Services catalogue 2019
Services catalogue 2019Services catalogue 2019
Services catalogue 2019
Matilde Beltrandi, PhD
 
Allware - Software development
Allware - Software developmentAllware - Software development
Allware - Software development
Santiago Rudnick
 
SHEZARTECH , Game Based Learning, Mobile Learning and eLearning Company
SHEZARTECH , Game Based Learning, Mobile Learning and eLearning CompanySHEZARTECH , Game Based Learning, Mobile Learning and eLearning Company
SHEZARTECH , Game Based Learning, Mobile Learning and eLearning Company
Shezartech
 
RSPL Brochure
RSPL BrochureRSPL Brochure
RSPL Brochure
Regulogix Solutions
 
Shree venkateshwara controls
Shree venkateshwara controlsShree venkateshwara controls
Shree venkateshwara controls
MarketingSVControls
 
Brochure_Application Outsourcing
Brochure_Application OutsourcingBrochure_Application Outsourcing
Brochure_Application Outsourcing
Stefan Forssman
 
Roadmap to next generation digital lab
Roadmap to next generation digital labRoadmap to next generation digital lab
Roadmap to next generation digital lab
Stephan Gürtler
 
Version1 database-managed-services-brochure
Version1 database-managed-services-brochureVersion1 database-managed-services-brochure
Version1 database-managed-services-brochure
Version 1
 
Calidad Infotech - About Us
Calidad Infotech - About UsCalidad Infotech - About Us
Calidad Infotech - About Us
Calidad Infotech
 
Validation Services
Validation ServicesValidation Services
Validation Services
RS Serve
 
Goip Profile
Goip ProfileGoip Profile
Goip Profile
krishangaur
 
Lab Optimizer
Lab OptimizerLab Optimizer
Lab Optimizer
BearingPoint
 
Codex validation Group presentation
Codex validation Group presentationCodex validation Group presentation
Codex validation Group presentation
Walter Acevedo
 
General Validation Presentation
General Validation PresentationGeneral Validation Presentation
General Validation Presentation
markaodonnell
 
DevOps Consulting Services | Automation Services - Codetru
DevOps Consulting Services | Automation Services - CodetruDevOps Consulting Services | Automation Services - Codetru
DevOps Consulting Services | Automation Services - Codetru
CODETRU Software Solutions
 
Company Presentation English
Company Presentation EnglishCompany Presentation English
Company Presentation English
Technowave
 
Copy of Cross ISG Biotech and Pharma
Copy of Cross ISG Biotech and PharmaCopy of Cross ISG Biotech and Pharma
Copy of Cross ISG Biotech and Pharma
Eli Jenkins
 
Chempharm Profile Presentation
Chempharm Profile Presentation Chempharm Profile Presentation
Chempharm Profile Presentation
CHUAN YAO
 
2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde
mikaelyde
 
ITMAGINATION - competences, facts, technologies, clients
ITMAGINATION - competences, facts, technologies, clientsITMAGINATION - competences, facts, technologies, clients
ITMAGINATION - competences, facts, technologies, clients
ITMAGINATION
 

Similar to Pqe brochure ph_english_june_2016 (20)

Services catalogue 2019
Services catalogue 2019Services catalogue 2019
Services catalogue 2019
 
Allware - Software development
Allware - Software developmentAllware - Software development
Allware - Software development
 
SHEZARTECH , Game Based Learning, Mobile Learning and eLearning Company
SHEZARTECH , Game Based Learning, Mobile Learning and eLearning CompanySHEZARTECH , Game Based Learning, Mobile Learning and eLearning Company
SHEZARTECH , Game Based Learning, Mobile Learning and eLearning Company
 
RSPL Brochure
RSPL BrochureRSPL Brochure
RSPL Brochure
 
Shree venkateshwara controls
Shree venkateshwara controlsShree venkateshwara controls
Shree venkateshwara controls
 
Brochure_Application Outsourcing
Brochure_Application OutsourcingBrochure_Application Outsourcing
Brochure_Application Outsourcing
 
Roadmap to next generation digital lab
Roadmap to next generation digital labRoadmap to next generation digital lab
Roadmap to next generation digital lab
 
Version1 database-managed-services-brochure
Version1 database-managed-services-brochureVersion1 database-managed-services-brochure
Version1 database-managed-services-brochure
 
Calidad Infotech - About Us
Calidad Infotech - About UsCalidad Infotech - About Us
Calidad Infotech - About Us
 
Validation Services
Validation ServicesValidation Services
Validation Services
 
Goip Profile
Goip ProfileGoip Profile
Goip Profile
 
Lab Optimizer
Lab OptimizerLab Optimizer
Lab Optimizer
 
Codex validation Group presentation
Codex validation Group presentationCodex validation Group presentation
Codex validation Group presentation
 
General Validation Presentation
General Validation PresentationGeneral Validation Presentation
General Validation Presentation
 
DevOps Consulting Services | Automation Services - Codetru
DevOps Consulting Services | Automation Services - CodetruDevOps Consulting Services | Automation Services - Codetru
DevOps Consulting Services | Automation Services - Codetru
 
Company Presentation English
Company Presentation EnglishCompany Presentation English
Company Presentation English
 
Copy of Cross ISG Biotech and Pharma
Copy of Cross ISG Biotech and PharmaCopy of Cross ISG Biotech and Pharma
Copy of Cross ISG Biotech and Pharma
 
Chempharm Profile Presentation
Chempharm Profile Presentation Chempharm Profile Presentation
Chempharm Profile Presentation
 
2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde
 
ITMAGINATION - competences, facts, technologies, clients
ITMAGINATION - competences, facts, technologies, clientsITMAGINATION - competences, facts, technologies, clients
ITMAGINATION - competences, facts, technologies, clients
 

Recently uploaded

VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
Vedanta A
 
Hyderabad Call Girls 7023059433 High Profile Escorts Service Hyderabad
Hyderabad Call Girls 7023059433 High Profile Escorts Service HyderabadHyderabad Call Girls 7023059433 High Profile Escorts Service Hyderabad
Hyderabad Call Girls 7023059433 High Profile Escorts Service Hyderabad
garge6804
 
Luxury Massage Experience at Affordable Rate - Malayali Kerala Spa Ajman
Luxury Massage Experience at Affordable Rate - Malayali Kerala Spa AjmanLuxury Massage Experience at Affordable Rate - Malayali Kerala Spa Ajman
Luxury Massage Experience at Affordable Rate - Malayali Kerala Spa Ajman
Malayali Kerala Spa Ajman
 
Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...
rightmanforbloodline
 
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
Media Logic
 
Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...
Nilima65
 
English Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptxEnglish Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptx
MatSouthwell1
 
Health Tech Market Intelligence Prelim Questions -
Health Tech Market Intelligence Prelim Questions -Health Tech Market Intelligence Prelim Questions -
Health Tech Market Intelligence Prelim Questions -
Gokul Rangarajan
 
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
5sj7jxf7
 
05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx
05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx
05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx
Santhosh Raj
 
The Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-TechThe Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-Tech
Gokul Rangarajan
 
nursing management of patient with Empyema ppt
nursing management of patient with Empyema pptnursing management of patient with Empyema ppt
nursing management of patient with Empyema ppt
blessyjannu21
 
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell
 
Columbia毕业证书退学办理
Columbia毕业证书退学办理Columbia毕业证书退学办理
Columbia毕业证书退学办理
ozcot
 
DAHL APPROACH a novel technique to raise bite
DAHL APPROACH a novel technique to raise biteDAHL APPROACH a novel technique to raise bite
DAHL APPROACH a novel technique to raise bite
SuraiyaTaranum
 
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
gjsma0ep
 
Bathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Bathinda
Bathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 BathindaBathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Bathinda
Bathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Bathinda
varun0kumar00
 
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdfchatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
marynayjun112024
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
Vishal kr Thakur
 
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
The Lifesciences Magazine
 

Recently uploaded (20)

VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdf
 
Hyderabad Call Girls 7023059433 High Profile Escorts Service Hyderabad
Hyderabad Call Girls 7023059433 High Profile Escorts Service HyderabadHyderabad Call Girls 7023059433 High Profile Escorts Service Hyderabad
Hyderabad Call Girls 7023059433 High Profile Escorts Service Hyderabad
 
Luxury Massage Experience at Affordable Rate - Malayali Kerala Spa Ajman
Luxury Massage Experience at Affordable Rate - Malayali Kerala Spa AjmanLuxury Massage Experience at Affordable Rate - Malayali Kerala Spa Ajman
Luxury Massage Experience at Affordable Rate - Malayali Kerala Spa Ajman
 
Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...Test bank clinical nursing skills a concept based approach 4e pearson educati...
Test bank clinical nursing skills a concept based approach 4e pearson educati...
 
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...
 
Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...Management of Post Operative Pain: to make doctors conscious about the benefi...
Management of Post Operative Pain: to make doctors conscious about the benefi...
 
English Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptxEnglish Drug and Alcohol Commissioners June 2024.pptx
English Drug and Alcohol Commissioners June 2024.pptx
 
Health Tech Market Intelligence Prelim Questions -
Health Tech Market Intelligence Prelim Questions -Health Tech Market Intelligence Prelim Questions -
Health Tech Market Intelligence Prelim Questions -
 
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
1比1制作(uofm毕业证书)美国密歇根大学毕业证学位证书原版一模一样
 
05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx
05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx
05 CLINICAL AUDIT-ORTHO done at a peripheral.pptx
 
The Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-TechThe Ultimate Guide in Setting Up Market Research System in Health-Tech
The Ultimate Guide in Setting Up Market Research System in Health-Tech
 
nursing management of patient with Empyema ppt
nursing management of patient with Empyema pptnursing management of patient with Empyema ppt
nursing management of patient with Empyema ppt
 
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
 
Columbia毕业证书退学办理
Columbia毕业证书退学办理Columbia毕业证书退学办理
Columbia毕业证书退学办理
 
DAHL APPROACH a novel technique to raise bite
DAHL APPROACH a novel technique to raise biteDAHL APPROACH a novel technique to raise bite
DAHL APPROACH a novel technique to raise bite
 
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
 
Bathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Bathinda
Bathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 BathindaBathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Bathinda
Bathinda ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 7742996321 ℂ𝕒𝕝𝕝 𝔾𝕚𝕣𝕝𝕤 Bathinda
 
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdfchatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
 
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
Cyclothymia Test: Diagnosing, Symptoms, Treatment, and Impact | The Lifescien...
 

Pqe brochure ph_english_june_2016

  • 1. Your Complete Quality Solution Provider for the Life Science Industry
  • 2. We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price. PQE at-a-glanceWHO IS PQE? • Quality and Compliance Solutions Provider – Complete Quality Solution Provider for our Customer’s GCP, GLP, GMP & GDP product development challenges since 1998. • Hundreds of compliance solutions consultants on staff, enabling rapid global deployment of flexible, well-organized project teams anywhere our clients require • Wide geographical coverage - offices throughout Europe and North and South America, the Middle East, India and China. • International references thousands projects completed worldwide. • Experts fluent in more than 20 languages. • Experience in working on regional/global projects and rollouts for large corporations. • Long history of supporting local leaders and small/medium companies in reaching FDA / EMA / ANVISA / WHO and other international, regional and local regulatory compliance authorities . • Proven methodology along with effective knowledge transfer mechanisms. • Exceptional focus on cost effectiveness, while maintaining the highest quality standards. • Internal instruments warehouse with “project ready” equipment validation & utilities qualification instrumentation with traceable calibration certificates. WHY PQE? Our broad services portfolio, extensive experience, effective project management, and exceptional cost effec- tiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.
  • 3. PQE / CORE BUSINESS Since the foundation of PQE, I have strongly believed that our core values, know-how, people and ethics, can make PQE the market leader for sustainable compliance solutions in Europe and beyond. As a matter of fact, we are growing year by year thanks to a full time workforce of dedicated employees, which allows us to enhance our robust and standardized commitment to excellence. Our passion for the growth and development of life science companies enables PQE to consistently exceed our customer’s expectations. This is the reason why we have suc- cessfully completed thousands of projects around the world, working in more than 20 different languages. Come discover what our customers have experienced. PQE: Your Partners in Excellence Gilda D’Incerti, CEO Data Integrity Assurance Global leader in full product life cycle computer system validation and IT compliance. Qualification & Engineering Your reliable partner for GMP Review, Facility Design, Qualification and Commissioning Activities. Regulatory Affairs A full service provider supporting companies through the entire regulatory lifecycle Compliance Leading global services for cGxP compliance needs.
  • 4. Data Integrity Data integrity may expose life science companies to significant regulatory and business risk. PQE’s multidisciplinary teams allow customers to achieve compliance and the Data Governance System, which is integral to a fully functional Quality System. The integrity of regulated data relies upon the validation of the computer system responsible for managing regulated data. As a proven global leader on this topic, PQE can support customers in the implementation of a cost effective and feasible validation strategy.This results in the assurance of the systems validation life cycle, which in turn enhances and improves product quality, patient safety and data integrity. PQE’s integrated approach enables client’s data integrity assurance and validation requirements through a scalable and fully regulatory compliant delivery model, based on a robust risk analysis. DATA INTEGRITY ASSURANCE • Data Integrity Policy • Computer Validation Strategy • Best Practices for Cost Saving & Quality of 21 CFR Part 11 compliance strategy • Validation Templates and System-specific Packages • 21 CFR Part 11 & EU GMP Annex 11 As- sessments • Risk-prioritized & Turnkey Remediation projects • 21 CFR Part 11 Inspection Readiness pro- jects • Data Integrity Historical Verification • Continuous Monitoring procedures for Data Integrity • Audit Trail Review Methodologies Capabilities:
  • 5. DATA INTEGRITY ASSURANCE Computer System Validation Computer System Validation has been PQE’s core business since its foundation in 1998. We have an unmatched track record of providing our clients with strategy and execution support with their FDA / EMA / WHO / TGA / SSA/ SFDA /ANVISA / INVIMA and other Local Regula- tory Body compliance projects. Our multidisciplinary team, which has extensive years of expe- rience, enables us to support our clients in turnkey validation projects for all types of compu­ terized systems: management information systems, systems from a manufacturing area and applications used in Laboratories. • Ongoing Adaptation of Risk based Compu- ter Validation Approach to current Regula- tory expectations • Computer Validation of Global and Local IT Systems (e.g. ERP, LIMS, MES) • Laboratory Systems Validation • Process Control Systems Validation • CSV Best Practices • Documentation Templates • User Requirements and Process Mapping • Data Migration Verification strategy and execution • System Testing (Unit & Integration Tests, UAT) • Validation Test Planning, Execution & Documentation • Best Practices Procedures to maintain the Validated status • Change Management • Periodic Reviews Capabilities:
  • 6. Regulated IT Solutions Regulated IT Solutions consists of a multidisciplinary team of professionals with a background in electronic engineering, software development, systems integration and information techno- logy. We are able to offer a broad spectrum of scalable services, thanks to our proven expe- rience in the field of IT solutions, infrastructure qualification and computer systems validation for life science companies. • Assessment of the compliance level of IT processes against international standards and guidelines (eg. GAMP, NIST, ITIL) • IT Infrastructure Qualification • IT Infrastructure design & implementation project management • Design and implementation of secure WANs • Selection and evaluation of hardware and software suppliers • Management and monitoring of system integrator • Design & management of server rooms and networks • Data housing and hosting services • Data archiving and retrieval • ERP suitability and gap analysis • Security standard assessment Capabilities: DATA INTEGRITY ASSURANCE
  • 7. Qualification & Commissioning Our service excellence is achieved through an interdisciplinary teamwork among engineers and technicians, who have a unique integrated knowledge in process engineering, information technology and quality in regulated environments. Due to our complete in house instruments park and our robust expertise in Pharmaceutical, Biopharmaceutical and APIs field, we can provide turnkey qualification solutions for process equipment and utilities qualification, based on the latest technologies and regulatory require- ments.This allows us to focus on minimizing compliance related risks and costs for our clients. • Qualification protocols writing and execution (Installation, Operational and Performance Qualification) • Validation Master Plan • Commissioning Plan • Cleaning Validation • Process Validation • Media Fill Protocols • Calibration services • Witnessing of Supplier Testing activities (FAT/SAT support) • Inventory of Process Equipment and Utilities • Quality Risk Management • User Requirement Specifications • Technology Transfer • Process Analytical Technology (PAT) Support • Clean Room Qualification • Temperature Mapping Services Capabilities: QUALIFICATION & ENGINEERING
  • 8. Facility Engineering There are many steps in the design of a pharmaceutical facility. In PQE’s approach and solu- tions, we emphasize delivery based on our three key project principles: TIME - COST - QUA- LITY. Our goal is to establish a partnership with our clients in order to create cost- and business- effective engineering solutions for Pharmaceutical, Biopharmaceutical, APIs and Medical De- vices facilities and to ensure that related national and international regulatory requirements are met. Due to our focus on Life Science, we always assess and design with the latest standards and with the point of view of the facilities end users. • Concept Development • Basic & Detail Design • Technology Transfer Support • Commissioning Support • GMP Review • Construction Supervision • Project Management • Visual Factory Programs • Procurement Support QUALIFICATION & ENGINEERING Capabilities:
  • 9. Regulated Laboratory Solutions PQE has multidisciplinary and specialized teams, which include engineers, chemists, biolo- gists and IT experts. Our aim is to support laboratories in the food and drugs industries, with independent and fully specialized services providing accurate and reliable analytical data in a fully regulated environment. • Data integrity and compliance • Purchasing and project coordination for new laboratories and renovation • Process mapping and solutions for a paperless lab • Analytical instrument qualification • Equipment calibration and maintenance plan • Analytical computer system validation • LIMS, Chromatography Data Software vendor selection, support and validation • Analytical method development and validation • Stability studies Capabilities: QUALIFICATION & ENGINEERING
  • 10. COMPLIANCE GMP & GDP Compliance We want to be sure that we understand your needs, in order to support, protect and help you thrive in all markets. Our aim is to help you be stronger and fitter. Our customized and cost- effective solutions for Quality (beyond compliance) are a competitive advantage; as non-com- pliance is an expense that no company can afford. PQE’s commitment is to help our customers identify problems with a proactive attitude, before they arise; this commitment will guide you to make your processes smarter and more efficient. Overall we will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy. Capabilities: • Compliance Strategies • Continuous improvement and performance metrics implementation • Risk Management implementation • Quality system implementation (corporate policies and local SOPs) • Quality structures (QC, QA, RA) assess- ments for skills and staffing • Inspection readiness Master Plans (FDA, EU, ANVISA, CFDA, PMDA, TGA etc) • Mock Inspections • Assistance during inspections/post-inspec- tion • Due diligence (Quality) of product and faci- lity acquisitions • Third party auditing • Supplier management and monitoring stra- tegies • Training systems implementation • Training in GMP/GDP compliance and to- pical matters • Mentoring/coaching • Support in critical event management (complaints, deviations, sterility/mediafill failures, recalls) • Change management support • CAPA System Implementation • Annual Product Review support • Data Trending
  • 11. GCP Compliance The development of a GCP Quality Management System (plan and resources) is the basis to promote and support compliance, while minimizing regulatory risk. PQE proposes the imple- mentation of a GCP quality strategy that will adapt to the Client’s requirements and support an effective and compliant conduction of clinical trials.This monitoring process ensures adequate protection of subjects, along with the quality and integrity of the clinical study data itself. In order to deliver leading GCP services to PQE clients, our consultants practice the most inno- vative Quality by Design and Quality Risk Management approaches related to clinical studies. PQE ensures a strong emphasis on the concepts of good quality control, with adequate do- cumentation throughout the delivery of a clinical trial by investigators and throughout all data management processes leading to a regulatory submission. Capabilities: • Self-assessment of GCP Quality System compliance against written standards (pro- cess mapping and gap analysis) • SOPs/Policies Development and admini­ stration • Audits: - CROs - eSystem providers - Centralized service providers (e.g. labo- ratories, cardiac safety) - Clinical database - Study Documents - Trial Master File • Site assessment (feasibility, compliance) • Inspection readiness (Sponsor, CRO, investigational site) • Inspection support (back and war room) • QA services and training COMPLIANCE
  • 12. PV Compliance In 2010, Regulatory Authorities raised the bar of compliance of the Pharmacovigilance System and an increasing number of countries are now performing routine regulatory inspections targeting Pharmacovigilance. An established quality system that is adequate and effective for performing pharmacovigilance activities has become a regulatory requirement. PQE can support the implementation of a pharmacovigilance quality system, starting from the compliance assessment of “AS-IS” scenario, which involves document editing and the quality system deployment at corporate or local level. The focus of PQE’s support is the compliance with applicable regulation as well as the suitability of the system to the company needs. Capabilities: • Self-assessment of Pharmacovigilance System compliance • Editing of quality documents (Policies/ SOPs/Working Instructions) • PSMF editing • Cleaning of safety database • SOPs review and deployment • Compliance monitoring • Preparation for Regulatory Inspection • Post inspection Follow-up • CAPA definition and implementation • Development of Training Plan • Pharmacovigilance Audits • Qualification of PV service providers • Data Migration Plan and Data Quality Control COMPLIANCE
  • 13. Third Party Audits • Manufacturers of API, Intermediates and Excipients (APIC certified Auditors) • Distributors of API • Contract Laboratories (GMP/GLP) • Manufacturers of Final Drug Forms • Distributors and Logistic Providers (GDP) • Software Suppliers (PDA and Tick-it certi- fied Auditors) • Contract Manufacturing Organisation • Laboratory Testing • Clinical & Pre-Clinic Audits • Investigational Site Audit • Sterilisation Facilities • Storage and Distribution • Suppliers of Equipment & Utilities Based on recent developments in pharmaceu- tical regulations, concerning starting materi- als and suppliers, qualification has become even more critical from the GxP perspective. Furthermore, EU and FDA regulators have emphasized that Third Party Audits are ac- cepted. By utilizing its experience in the Life Science sector, PQE supports manufacturers in performing many kinds of audits, conduc- ted worldwide by our lead auditors that have a minimum of 15 years of field experience. Capabilities: Learning Management and Knowledge Transfer • Computer System Validation (GAMP, 21CFR Part 11, IT infrastructure) • FDA Inspection Readiness • Quality Management System • Process Equipment Qualification • Laboratory Equipment Qualification • Process Validation • Analytical Methods Validation • Regulatory Affairs • Risk Management • GCP Compliance and Clinical Trials • Process Analytical Technology • Technology Transfer • Pharmacovigilance PQE offers cost effective practical training courses based on latest industry guidance, regulations and real life experience. All cour- ses are full of examples, case studies, and are held by our top class executive consul- tants. Courses can be organized both at funda- mental and advanced levels based on the fol- lowing topics: Capabilities: COMPLIANCE
  • 14. REGULATORY AFFAIRS Regulatory Affairs PQE supports customers through the entire drug regulatory lifecycle, providing a full range of regulatory activities. Our service begins with the development of the regulatory strategy and concludes with the editing, amendment and submission of the necessary documents of the dossier. Due to the expertise of our consultants, fully electronic submissions for the EU / USA, along with paper submissions are handled in the fastest and most professional manner, while ensuring that dossiers are compliant to the strictest regulations. Capabilities: • Regulatory Strategy for EU, USA, LATIN AMERICA, CANADA and other countries • Dossier gap analysis and review for Drug Products and Drug Substances • DMF / ASMF / CEP Dossiers preparation in eCTD or NeeS format • Preparation of Product Registration Dossiers (Quality part) • Country-specific Module 1 • Expert Reports, Overviews and Summaries • Investigational Medicinal Product Dossiers • Variation/Change application Dossiers • Reformatting of documents to eCTD compliant submissions • Drug Listing • Support for electronic submission
  • 15. HEADQUARTERS Località Prulli, n°103/C • 50066 Reggello • (FI) • Italy Tel. +39 055 52 75 100 • Fax +39 055 52 75 142 www.pqe.eu • info@pqe.eu Offices and Representatives Brazil | China | Ecuador | Germany | India | Israel | Italy | Japan | Mexico | Spain | Switzerland | Turkey | United States We support you globally while delivering locally