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About CCRA

Pharmaceutical Development Services Ltd
Shanakiel, 17 Ilkeston Road
Heanor
DE75 7DT

Tel: +44 (0)115 896 2358
Fax: +44 (0)115 912 4278

Web: www.pharmdservices.com


Pharmaceutical Development Services Ltd (PDS) provides an integrated drug development consultancy service from the early preclinical stages through to registration of the drug with the regulatory authorities.

The pharmaceutical development consultancy includes formulation development, manufacturing and production strategy, contractor identification and management, and project management. This enables a development project to be managed on behalf of a client.

The quality and compliance service includes facility audits (to GMP, ISO 9000, PS9000 and PS9001), SOP writing, QP release and quality strategy implementation. There is also a complete regulatory affairs service with regulatory strategy, the compiling of regulatory documents such as CTAs and MAAs, and pharmacovigilance.

PDS purchased the assets and goodwill of Tudor Health Care in early 2005, which provides additional regulatory capabilities for pharmaceutical and biotechnology products, as well as for OTC products, herbal medicines, nutraceuticals, cosmetics and class 1 medical devices.

Group Sector:

  • Pharmaceutical Development
  • Quality and Compliance
  • Regulatory Affairs

Geographical Area:

  • Worldwide

Contact

Michael Gamlen BSc MRPharmS PhD Managing Director
Janet Ellis PhD MRPharmS MTOPRA - Director of Regulatory Affairs


CCRA is a not-for-profit organisation originally founded to represent independent clinical research contractors and allied industries.