Profile  

Master degree and Ph. D. in Chemistry with more than 20 years of experience in the pharmaceutical industry in regards to develop, control and registration of
drug substances and related drug products as well as GMP related matter


In charge of:
• Qualified Person due to release of drug substances
• Head of Production for APIs
• Head of Quality Control for APIs
• Responsible Person for Drug product wholesaling

Countries/cultures:
• Europe: European Union, Ukraine, Turkey, Russia
• Asia: China, India, Taiwan
• America: Mexico, USA, Canada, Brazil

Regulatory Affairs- Expertise:
• > 20 CEPs
• > 20 EDMFs/ASMF filings
• > 10 USDMF filings

SCHECON - Scheske Pharma-Consulting    •    Dr. Stephan Scheske    •    Tel: + 49 (0) 4131 404 899     •    Fax: + 49 (0) 4131 404 837    •    email: scheske@schecon.net