PQE-Pharmaceutical Services (English)

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