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