Regulatory Affairs -
Pharmaceutical Development Services

Pharmaceutical Development ServicesPharmaceutical 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

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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

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