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Regulatory and Drug Development Advisory Service

More info about 3R PHARMA CONSULTING

Quality Aspects


3R PHARMA CONSULTING understands that successful pharmaceutical development begins with well-designed experiments (DoE), and thorough strategic planning.

Alongside state-of-the-art technology, 3R PHARMA CONSULTING’s knowledge and experience allows manufacturers to predict production performance and quality, as opposed to controlling them on the finished product.

The company provides regulatory advice and services covering quality-related aspects of pharmaceutical development aiming for fast submissions and approvals.

3R PHARMA CONSULTING’s quality aspect services include:

  • Strategic and scientific/technical advice on the development of pharmaceutical products. The company’s advice meets current regulatory requirements and standards in relation 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 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 good manufacturing practice (GMP) audits of active pharmaceutical ingredients (API) manufacturers and suppliers
  • Review and evaluate quality-related data and reports
  • The organisation and attendance of meetings with regulatory agencies
  • Generation of reports, summaries, expert statements and 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), marketing authorisation applications (MAA) in Europe or new drug applications (NDA) in the US, applications for variations, line extensions and renewals, drug master files (DMF) / active substance master file (ASMF), European drug master files (EDMF) and certification of suitability of monographs of the european pharmacopoeia (CEP)
  • Due diligence evaluations of CMC documents offered for in-licensing
  • Advice on go/no-go decisions
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