Parexel Consulting Strengthens Good Manufacturing Practice Capabilities...(Roche. Dr. Schmitt is a Member of the Ro...)

Date:9/18/2007

Roche. Dr. Schmitt is a Member of the Royal Society of Chemistry and is a Chartered Chemist and Chartered Scientist. He is also a member of several industry organizations, and was recently elected U.K. Chapter President of the Parenteral Drug Association (PDA). Dr. Schmitt presents at international conferences and he is the editor and author of various books and publications.

Expertise and services provided by PAREXEL Consulting in the areas of strategic compliance and operational performance excellence include:

-- Quality strategy for handling complex process technologies

-- GxP (Good Laboratory Practice, GMP, and Good Clinical Practice)

compliance and inspection readiness for EU and non-EU markets

-- Manufacturing planning and site inspection readiness

-- Technology transfer

-- Pre-approval inspection management

-- Post-approval change and file compliance

-- Integration of regulatory changes into Quality Systems

-- Counterfeit control development

-- Manufacturing sourcing strategy

-- Pharmacovigilance management and systems

-- Development, risk management, and Quality Systems strategy and

approaches to ICH* guidelines

-- Process and organizational excellence

-- Merger and acquisition integration

* International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use

About PAREXEL Consulting

PAREXEL Consulting is a leading life sciences consultancy that helps companies design and execute their biopharmaceutical and medical device product strategies through our unique fusion of scientific, regulatory, and business expertise. Our approach helps clients manage risk, and drives superior quality and performance for clients worldwide. The firm has approximately 270 employees in seven major office locations in the U.S. and Europe, and serves clients on a global basis. For further information visit:
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