Regulatory Affairs -
Pharmaceutical Development Services
Pharmaceutical Development Services is one of Europe's leading pharma consultancies.
We'll manage your drug or device development programme from research to product launch.
PDS was established in 2000 by Michael Gamlen, Managing Director and a number of senior colleagues, who are all experts in formulation development, manufacturing, quality assurance, regulatory affairs and clinical trials. In 2004 PDS bought Tudor Health Care, a long established regulatory consultancy with complementary expertise. The head office near Nottingham was retained and there is also an office in Guildford. PDS offer consultancy for UK, EU and international companies and organisations.
We have worked for small start up companies, major multinationals, US and European based biotechnology companies, generic manufacturers, US based medical device companies and multinational OTC Health Care providers.
Our trusted experts will ensure you receive the best advice and help to get your products to market
Sectors Served
- Pharmaceuticals (Prescription and OTC)
- API Synthesis
- Biotechnology
- Medical Devices
- Herbal Remedies and Borderline Substances
- Cosmetics
Services Include
- Regulatory Affairs
Development of Regulatory Strategy for Clinical Trial Programmes and Marketing Authorisations in the EU
Regulatory Due Diligence for potential In-licensing Candidates
Preparation for Scientific Advice meetings with the EMEA and National Agencies
Management of Centralised, Decentralised and Mutual Recognition Procedures
Responding to Regulatory Questions
Compilation of Clinical Trial Applications, including IMPD writing, and Submission to National Agencies and Ethics Committees
Compilation of Marketing Authorisation applications in e-CTD Format
Medical Device Registration
Advice on Permitted Ingredients and Claims for Cosmetics - Pharmacovigilance
Advice on establishment of a pharmacovigilance
Provision of a 24 hour Telephone Answering Service for Adverse Event Monitoring
Provision of a Pharmacovigilance Qualified Person service
Reporting of Serious Adverse Drug Reactions to EU agencies
Preparation of Periodic Safety Update Reports (PSURs) - Pharmaceutical and chemical services
Project Management of all aspects of Product Development
Successful Outsourcing of Pharmaceutical and Chemical Development
Management of Packaging, Labelling and Manufacturing of Clinical Trials Materials
New product development on an out-sourced basis
Identification of low cost, high quality API and synthetic intermediate sources
Technical Due Diligence
Supply Chain Development and Management - Quality Services
Reliable QA Advice and Biotech QC Specialist
Inspections without fear
Contractor Management
Support for your QP and Contract QP
Clinical Trial Materials release - Medical Writing
Preparation of Clinical Study Reports
Preparation of IMPDs and Investigator Brochures
Writing Non-clinical and Clinical Overviews and Summaries in accordance with CTD Requirements - Interim Management
Independent support for your team in the regulatory and QC areas
Laboratory Management - Training
In-house and public courses covering all aspects of product development and supply change management including GMP, Six Sigma, Lean Manufacturing, Pharmacokinetics, Auditing, Stability Testing, Tablet Development and Regulatory Affairs - Formulation and Manufacturing Development