1. Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
2. They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
3. Case studies show Pharmalink's ability to successfully manage large, long-term global regulatory compliance projects for top pharmaceutical companies, ensuring on-time delivery and sustainable compliance.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
Activities of India's leading Software Validation company. We mainly focus on International job , GAP Analyses, 483 - warning letter replies and Remedies, Training to Staff on Data Integrity, 21 CFR Part 11 Compliance, Computer Systems Validation, Annex 11, GAMP5 and make them walk the talk. Say what you Do and Do what you Say
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
Activities of India's leading Software Validation company. We mainly focus on International job , GAP Analyses, 483 - warning letter replies and Remedies, Training to Staff on Data Integrity, 21 CFR Part 11 Compliance, Computer Systems Validation, Annex 11, GAMP5 and make them walk the talk. Say what you Do and Do what you Say
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Patrys Limited ' Product Pipeline Review ' 2012
Summary
Global Markets Direct's pharmaceuticals report, 'Patrys Limited - Product Pipeline Review - 2012' provides data on the Patrys Limited's research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects. This report is built using data and information sourced from Global Markets Direct's proprietary databases, Patrys Limited's corporate website, SEC filings, investor presentations and featured press releases, both from Patrys Limited and industry-specific third party sources, put together by Global Markets Direct's team.
Scope
- Patrys Limited - Brief Patrys Limited overview including business description, key information and facts, and its locations and subsidiaries.- Review of current pipeline of Patrys Limited human therapeutic division.- Overview of pipeline therapeutics across various therapy areas.- Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, across the globe.- Product profiles for late stage and clinical stage products of Patrys Limited with complete description of the product's developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Patrys Limited's pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products.
Reasons to buy
- Evaluate Patrys Limited's strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Patrys Limited in its therapy areas of focus. - Identify new drug targets and therapeutic classes in the Patrys Limited's R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas. - Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps. - Exploit collaboration and partnership opportunities with Patrys Limited. - Avoid Intellectual Property Rights related issues. - Explore the dormant and discontinued projects of Patrys Limited and identify potential opportunities in those areas.
CoreRx is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Treated articles refers to items treated with pesticide or preservative. Learn about the regulatory requirements for selling treated articles in Canada.
Artixio MedTech Training Brochure 2023.pdfY. Yogi Raj
Product Technical Documents for Regulatory Submissions
Regulatory Submissions - US FDA
Regulatory Submissions - EU
The Medical Device Regulation (MDR)
The In Vitro Diagnostic Medical Device Regulation (IVDR)
ISO 13485:2016 - General Overview and Training
Risk management ISO 14971
Regulatory Submissions - APAC
Regulatory Submissions - LATAM
Regulatory Submissions - ANZ
Quality Management System - Development
Quality Management System - Implementation
Labelling for Global Regulatory Submissions
UDI - EUDAMED Requirements
Medical Writing for Regulatory Submissions
Clinical Evaluation - Plan and Report
Performance Evaluation - Plan and Report
Post Marketing Surveillance Requirements
Medical Device Standards Training
Notified Bodies Experience
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Patrys Limited ' Product Pipeline Review ' 2012
Summary
Global Markets Direct's pharmaceuticals report, 'Patrys Limited - Product Pipeline Review - 2012' provides data on the Patrys Limited's research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects. This report is built using data and information sourced from Global Markets Direct's proprietary databases, Patrys Limited's corporate website, SEC filings, investor presentations and featured press releases, both from Patrys Limited and industry-specific third party sources, put together by Global Markets Direct's team.
Scope
- Patrys Limited - Brief Patrys Limited overview including business description, key information and facts, and its locations and subsidiaries.- Review of current pipeline of Patrys Limited human therapeutic division.- Overview of pipeline therapeutics across various therapy areas.- Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, across the globe.- Product profiles for late stage and clinical stage products of Patrys Limited with complete description of the product's developmental history, mechanism of action, therapeutic class, target and major milestones. - Recent updates of the Patrys Limited's pipeline in the last quarter. - Key discontinued and dormant projects. - Latest news and deals relating to the products.
Reasons to buy
- Evaluate Patrys Limited's strategic position with total access to detailed information on its product pipeline. - Assess the growth potential of Patrys Limited in its therapy areas of focus. - Identify new drug targets and therapeutic classes in the Patrys Limited's R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas. - Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps. - Exploit collaboration and partnership opportunities with Patrys Limited. - Avoid Intellectual Property Rights related issues. - Explore the dormant and discontinued projects of Patrys Limited and identify potential opportunities in those areas.
CoreRx is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Treated articles refers to items treated with pesticide or preservative. Learn about the regulatory requirements for selling treated articles in Canada.
Artixio MedTech Training Brochure 2023.pdfY. Yogi Raj
Product Technical Documents for Regulatory Submissions
Regulatory Submissions - US FDA
Regulatory Submissions - EU
The Medical Device Regulation (MDR)
The In Vitro Diagnostic Medical Device Regulation (IVDR)
ISO 13485:2016 - General Overview and Training
Risk management ISO 14971
Regulatory Submissions - APAC
Regulatory Submissions - LATAM
Regulatory Submissions - ANZ
Quality Management System - Development
Quality Management System - Implementation
Labelling for Global Regulatory Submissions
UDI - EUDAMED Requirements
Medical Writing for Regulatory Submissions
Clinical Evaluation - Plan and Report
Performance Evaluation - Plan and Report
Post Marketing Surveillance Requirements
Medical Device Standards Training
Notified Bodies Experience
Raaj Global Pharma Regulatory Affairs Consultants Thane-mumbai profile-updat...Rajashri Survase Ojha
Raaj-GPRAC is a Thane-Mumbai (India) based agency.
Our offerings includes but not limited to making Regulatory filing strategy, Preparation of pharmaceutical product registration dossier, filing assistance, response to regulatory queries, life cycle management, regulatory compliance audit and Training.
We offer flexible and need based services to meet customer/client requirements so as to save time and cost.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...balakrishna t
tQmlab® is the premier management system for GxP operations and for supporting regulatory submissions. It delivers transformational productivity for QA/QC labs supporting customised workflows for quality control of drugs, stability testing, product release testing and post-release quality testing.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
4. Who we are
Founded in UK in 1998
Privately held
Leading independent Regulatory Affairs
Specialist
Offices in Europe, US, India and Asia-Pacific
155 Staff as of May 2011
Large, proprietary network of freelance RA
professionals worldwide
Revenues in excess of $25 million in 2010
5. Who we work with
18 of top 20 healthcare companies
Large pharmaceutical multinationals
Consumer Health organizations and divisions
Biotechnology & new technology
Clinical research organizations
Medical device companies
Generic companies
Start-up ventures
Virtual companies
6. Consumer Profile
Pharma
Biotech
Medical device
Consumer Health
Veterinary
Generics
Nutraceuticals/Other
8. What we can help with
Projects of any scale or duration
Domestic, international and multinational
projects
Interim regulatory staffing needs
Assistance at all stages of regulatory lifecycle
9. What we can help with
Non-clinical
Clinical Development
Pre-Submission Activity
Filing / Submission
Approval
Product Launch
Post-Approval
10. RA Solutions that fit your business
REGULATORY Regulatory Strategy Clinical Advertising &
Promotion/Labeling
SERVICES Regulatory agency Preparation of
meetings CTD Module 2 & 5 USPI/PLR/SPC/CDS
Filing strategy Review of protocols & User testing
Response to agency CSRs Packaging
queries CTA preparation
Advisory Committee Review of IBs
preparation Regulatory Operations
CMC & Manufacturing IRB/EC documentation
Scientific Advice
Compliance Orphan indication CTD/eCTD/dossier
Lifecycle management preparation
Pediatric development
Gap analysis & remediation Input from Subject Matter plans Submission advice
Experts
Preparation of Amendments Translation service
CTD Module 2 & 3 Medical writing
Filing Expertise
DMF preparation GCP audit Non-clinical
Validation IND/IMPD
TPM site identification Original NDA/MAA Postmarketing Maintenance Preparation of
Contract QP ANDA CTD Module 2 & 4
Import documentation and sNDA/variations Review of toxicology &
BLA pharmacology studies
licensing Annual Reporting
510K/PMA
GLP/GMP audit Postmarketing Commitments
Pre-approval inspections Safety reporting eg PSUR
11. RA Solutions that fit your business
A Regulatory Affairs team for
all your regulatory needs
Junior consultants to Subject Matter Experts
Generalists to specialists
Assistance with projects of any scale and
length
On-site or remote working on Domestic,
International, and Multinational assignments
12. How we work
Project are served by appropriate experience
– 30+ yrs to 1 yr depending on requirements
– Mainstream or specialized experienced
– Industry and/or Agency expertise
Senior Regulatory Managers assisted by
junior level staff for data intensive work
14. Global experience
Our consultants have experience in the
following regions:
Europe (EU, Switzerland, Norway, Iceland)
Middle East and Africa
North America and Canada
Central America and Caribbean Community
Latin America
Central & Eastern European states
Australia & New Zealand
Asia-Pacific
15. Global Pharmalink Offices
Cambridge, MA
Short Hills, NJ
King of Prussia, PA Maidenhead, UK
Singapore
San Francisco, CA
Mumbai, India
Hartford, CT
Washington, DC
New York, NY
Durham, NC
17. Pharmalink Affiliate Network
Access to local Regulatory Affairs
expertise when and where you need it.
The best Regulatory Affairs professionals in every
continent.
Covering every market from Argentina to Zambia.
Leading local consultants who:
– understand the culture
– will ensure your requirements are met
– save you time and money.
18. Pharmalink Affiliate Network
EUROPE
AUSTRIA | BELGIUM | CYPRUS | CZECH REPUBLIC | DENMARK | FINLAND
FRANCE | GERMANY | GREECE | IRELAND | ITALY | NETHERLANDS
PORTUGAL | SPAIN | SWEDEN | SWITZERLAND | TURKEY | UK (GLOBAL HQ)
19. Pharmalink Affiliate Network
ME-NA
ALGERIA | BAHRAIN | EGYPT | ISRAEL | JORDAN | KUWAIT | LEBANON
MOROCCO | OMAN | QATAR | SAUDI ARABIA | TUNISIA | UAE
20. Pharmalink Affiliate Network
AFRICA
ANGOLA | BOTSWANA | DEMOCRATIC REPUBLIC OF CONGO | LESOTHO
MADAGASCAR | MALAWI | MAURITIUS | MOZAMBIQUE
NAMIBIA | SOUTH AFRICA | SWAZILAND | TANZANIA | ZAMBIA | ZIMBABWE
21. Pharmalink Affiliate Network
EASTERN
EUROPE
ALBANIA | AZERBAIJAN | BOSNIA & HERZEGOVINA | BULGARIA | CROATIA
ESTONIA | GEORGIA | HUNGARY | KAZAKHSTAN
KOSOVO | MACEDONIA | MOLDOVA | MONTENEGRO | POLAND | ROMANIA
RUSSIA | SERBIA | SLOVAKIA | SLOVENIA | UKRAINE | UZBEKISTAN
22. Pharmalink Affiliate Network
ASIA PAC
AUSTRALIA | CHINA | HONG KONG | INDIA
JAPAN | MALAYSIA | NEW ZEALAND | PHILIPPINES | SINGAPORE
SOUTH KOREA | THAILAND
24. Pharmalink Affiliate Network
ARGENTINA | ARUBA | BELIZE | BRAZIL | CHILE | COLOMBIA | COSTA RICA
DOMINICAN REPUBLIC | ECUADOR | EL SALVADOR | GUATEMALA
HONDURAS | JAMAICA | MEXICO | NICARAGUA
PANAMA | PARAGUAY | PERU | PUERTO RICO | TRINIDAD | VENEZUELA
LATIN
AMERICA
26. Case Study 1
Major regulatory compliance project
CLIENT A major pharmaceutical company based in Europe.
PROJECT A large compliance project.
OBJECTIVE Review all European-registered licenses and bring into
compliance with current manufacturing site practices.
SOLUTION Pharmalink provided a dedicated team of regulatory affairs
specialists to work on the project for 3 years.
One of the key advantages that Pharmalink was able to bring to the project
was the ability to adjust the number of consultants working on the project to
fit the client’s needs and hit every deadline whilst always maintaining the
level of quality.
27. Case Study 1
Project Details
Consultants reviewed registered details against manufacturing site
documents, highlighting compliance issues.
Consultants worked with site QA departments in preparing remediation
plans for each license.
Over 600 licenses were reviewed and each phase of the project was
delivered to the client’s timelines.
Pharmalink’s staff exceeded the client’s expectations on each phase of
the defined project, resulting in the client engaging Pharmalink to
prepare all of the Variations and submit to all EU agencies in order to
bring the product licenses into compliance.
28. Case Study 2
Global Product Compliance Project
CLIENT Top 10 Pharma Company.
PROJECT Since 2004, Pharmalink Consulting have been successfully
performing a large-scale Global Quality Compliance program for a
company, covering approximately 1400 Quality Dossiers
worldwide.
OBJECTIVE
Short term – get product moving around Europe again.
Long term – bring all dossiers and licenses up to date providing
sustainable compliance.
SOLUTION
The team that Pharmalink Consulting assembled has successfully
driven all key stages of the compliance process including:
– Quality Dossier collection and collation into
CTD format
– CMC Compliance Assessment
– Product Remediation
29. Case Study 2
Project Details
Dossiers Collected – 270
Dossiers Collated – 270
Compliance Assessments Performed - 270 (10% TPM)
Remediation Packages Prepared – 564
Markets -
AT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU,
IE, IS, IT, LT, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK
30. Case Study 2
Project Details
Throughout the compliance project in Europe, the Company was forced
to halt product shipment until gap analysis was completed. This put
enormous pressure on the team, yet the impact on product shipments
remained minimal.
Various stages of the compliance process were performed remotely from
the client, across the Pharmalink offices in North America, Europe and
Asia. All objectives and milestones were successfully achieved ahead of
target dates.
The Pharmalink team reached 45 in number at the height of the activity
but remained flexible dependent on the workload so were able to adjust
accordingly. Pharmalink was able to offer office facilities for the purposes
of the project.
The resulting completion of the European section of the project meant a
satisfied client who has continued to employ Pharmalink for regulatory
activities across multiple sites in Europe and the United States.
31. Case Study 3
Organization Acquisition Project
CLIENT Top 10 Pharma Company.
PROJECT Since 2004, Pharmalink have been involved with a large scale
global integration project.
OBJECTIVE Short term – Assemble and assess documentation.
Long term – complete ownership changes and related regulatory
activity to bring dossiers and licenses in line with parent company.
The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of
the compliance process including:
- data gathering - reviewed existing documentation, job descriptions,
SOPs, job aids, interviewed staff
- Mapped process(es) - deployment,
interactions, comparison against best practice
- Recommendations presented to sponsor –
Appropriate to the organization concerned
32. Case Study 3
Project Details
Project sponsorship – It was important to get high level buy-in and support and
confirm mutual understanding of deliverables and objectives. At an early stage
effective communication and ‘marketing’ of activities was developed to overcome
potential issues.
Environmental issues – Given the cultural differences between sites, areas of
organisation Pharmalink worked with the project sponsor to identify the potential
roadblocks to a successful outcome – Often M&A ‘fallout’ can present barriers to
success.
The Pharmalink team adjusted the resources at various stages to deal with short
term increases in workload, but remained flexible. Pharmalink was able to offer
office facilities for the purposes of the project.
The resulting completion of the integration meant that the organization was able to
operate a ‘business as usual’ model, despite the uncertainty and disruption
associated with many mergers and acquisitions. A satisfied client who has
continued to employ Pharmalink for regulatory activities across multiple sites in
Europe and the United States.
33. Case Study 4
Merger & Quality Compliance Project
Large Pharmaceutical Company
CLIENT Top 10 Pharma Company.
PROJECT Since 2000, Pharmalink Consulting have been engaged in an
operational role in a license integration, site rationalization, and a
quality compliance project.
OBJECTIVE Short term – Assist client company meeting legal and commercial
obligations and targets as a result of merger.
Long term – complete source transfers and related regulatory activity
to enable seamless supply chain.
SOLUTION The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of the
compliance process including:
– site transfers including internal and TPM sites,
covering markets worldwide.
– Performed quality & compliance reviews.
34. Case Study 4
Project Details
Pharmalink was the operational regulatory partner in the UK and US for site
rationalisation and product quality compliance resulting from a high profile
merger between two large pharmaceutical companies. The key performance
indicator was the need for cost saving and manufacturing rationalisation –
central to these activities.
Pharmalink was tasked with identifying requirements, timing, and delivering site
transfers for worldwide markets. In parallel with this activity the team completed
a quality compliance review on all products that enabled a full regulatory strategy
to be available when sourcing decisions had to be made.
The Pharmalink core team of 25 was adjusted as requirements varied and
reached 60 at its peak. Following the merger activity in 2005 Pharmalink has
maintained smaller team to continue routine source transfers.
The volume and complexity of the project was managed successfully and key
merger targets achieved. The client was satisfied and continues to employ
Pharmalink for a variety of regulatory activities across its sites.
38. What else can we offer you?
1. We have demonstrable capability and
experience with large scale multi-product,
multi-national regulatory projects on
behalf of Top-20 healthcare companies.
Our familiarity with such sizeable projects
provides our clients with assurance that
the desired results can be achieved for any
project of any size.
39. What else can we offer you?
2. Our global regulatory teams are comprised
of consultants with a wide range of skills
and levels of experience.
This allows us to be able to meet client
requirements while ensuring that costs are
kept to a minimum by using the right level
of consultant for the various tasks.
40. What else can we offer you?
3. The infrastructure, both in terms of systems
and people, that we have established and in
which we have invested, underpins our
ability to undertake projects of varying scale.
We have a purpose-built, centrally-managed
IT network for all of our offices worldwide.
This will ensure peace of mind as we are
able to segregate and secure individual
company data while allowing for flexible
access.
41. What else can we offer you?
4. Whilst Pharmalink Consulting is now a
multi-national consultancy that is
recognized as a global leader in Regulatory
Affairs, we remain nimble and flexible to
react to our clients’ often urgent
requirements.
42. Thank you
UK: + 44 1628 860300
MAIDENHEAD, BERKSHIRE
USA: + 1 800 434 5808
SHORT HILLS, NJ | CAMBRIDGE, MA | HARTFORD, CT | MANHATTAN, NY | KING OF PRUSSIA, PA
DURHAM, NC | SAN FRANCISCO, CA | WASHINGTON, DC
INDIA: + 91 22 4030 9595
MUMBAI
SINGAPORE: + 65 6408 0515