QUALITY COUNTS IN EVERY STAGE

Successful pharmaceutical development starts with well designed experiments (DoE) and sound strategic planning. Knowledge and experience combined with modern technology will help manufacturers to predict manufacturing performance and quality instead of controlling them on the finished product.

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:

  • Strategic and scientific/technical advice on the development of pharmaceutical products meeting current and future regulatory requirements and standards with regard to manufacturing and quality control;
  • Advice on Process Analytical Technology (PAT) and Quality by Design (QbD) to get a Design Space agreed with the authorities in order to increase regulatory flexibility - in line with ICH Guideline Q8 and Q9;
  • Advice on Real Time Release (RTR) to replace end-product testing;
  • Qualified Person (QP) according to Directive 2001/83/EC, Art. 49 and 51;
  • Conducting external GMP audits of API manufacturers and suppliers; 
  • Review and evaluation of quality related data and reports;
  • Organisation of and attendance at meetings with regulatory agencies;
  • Generation of reports, summaries, expert statements, briefing books;
  • Generation and signing of Module 2 Quality Overall Summaries (QOS) for drug substances and products
  • 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 and ANDA in the US),
    • Applications for variations,
    • Applications for line extensions,
    • Applications for renewals.
    • Drug Master Files (DMF) / Active Substance Master File (ASMF), commonly known as the European Drug Master File (EDMF)
    • Certification of suitability of monographs of the European Pharmacopoeia (CEP)
  • Due diligence - evaluation of CMC documents offered for in-licensing.
  • Advice on go/no-go decisions