PDQ Services Limited

PHARMACEUTICAL DEVELOPMENT AND QUALITY SERVICES LIMITED

Pharmaceutical Development and Quality Services Limited brings a wide range of experience within the reach of start-up and small to medium sized pharmaceutical companies as and when needed. Without having to employ someone permanently you can focus knowledge and experience of European and U.S. regulatory requirements on priority tasks such as:

· Developing formulation strategies for new drugs

· Devising and implementing quality systems for research and development

· Auditing manufacturers of active pharmaceutical ingredients and of medicinal products

· Selecting and managing contractors for the development, manufacture, packaging and analysis of investigational medicinal products in compliance with GMP

· Qualified Person release of clinical trial and commercial products

· Writing pharmaceutical expert reports

· Writing chemistry and pharmacy dossiers

· Conducting due diligence assessments for licensing and acquisition opportunities

· Management of product development projects

This approach conserves your resources yet assures a high level of confidence of getting it right first time and reduces the time to get new products to market or to intermediate milestones in the drug development process.

Also, through PDQ Services you can access a network of people highly skilled and experienced in Good Clinical Practice, Good Laboratory Practice, Regulatory Affairs and related areas of drug development.

PDQ Services operates internationally and is headed by Roger Withington B.Pharm., Ph.D., C.Chem., F.R.S.C., M.R.Q.A.

Dr Withington has more than 30 years experience in all aspects of pharmaceutical development with a range of companies. He has held senior industry positions with responsibility for Product Development, Manufacturing, Quality and Regulatory Affairs. He is eligible to act as a Qualified Person for the release of commercial and investigational medicinal products and, from 1994 to 2001, he was a member of the Pharmacy Committee of the British Pharmacopoeia Commission.

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