Range of Service
Service and Expertise
APIs and Drug Products – Drug Master File and Dossier
• Assessment and review of available data and files in regards to individual
needs and local requirements comprising written assessment reports and
corrective measures
• Compilation of CMC documentation (CTD module 3.2.S)
• Compilation, re-compilation and update of Active Substance Master
Files/API-dossiers including Applicants Part
Restricted Part, Quality Overall Summary
• CEP/COS applications and procedures
• Work on deficiency letters
SCHECON - Scheske Pharma-Consulting
• Dr. Stephan Scheske
• Tel: + 49 (0) 4131 404 899
• Fax: + 49 (0) 4131 404 837
•
email: scheske@schecon.net