QUALITY COUNTS IN EVERY STAGE

3R PHARMA CONSULTING provides regulatory advice and service covering Quality-related aspects of pharmaceutical development aiming at fast submissions and approvals of applications.

What we offer:

• Qualified Person (QP) according to Directive 2001/83/EC, Art. 49 and 51;
• Generation of reports, summaries, expert statements, briefing books;
• Generation and signing of Module 2 Quality Overall Summaries (QOS) for active substances and medicinal products for human use;
• Compilation of Common Technical Document (CTD) Module 3 required for
  • Clinical Trial Applications (CTA, IND),
  • Applications for Marketing Authorisations (MAA in Europe) or New Drug Applications (NDA, BLA and ANDA in the US),
  • Drug Master Files (DMF) / Active Substance Master File (ASMF)
  • Certification of suitability of monographs of the European Pharmacopoeia (CEP)