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:
- 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;
- 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)