Quality/CMC
- Writing & updating of CMC documentation (IMPD, Module 3, Module 2, ASMF) according to guidelines and company strategy including Quality by Design approach (ICH Q8, Q9, Q10 & Q11).
- Gap analysis, critical review of CMC dossiers (Module 3 and Module 2).
- Quality Expert (Signature of Module 1.4.1).
- Regulatory assessment of change controls (Trackwise).
- Response to Agencies’ questions
- Writing, critical review and compilation of variations on manufacturing changes, new data, manufacturing transfer, Line extension for a new formulation, new indication….
- GMP audits and inspections
- Training on new regulations.
- Writing of SOPs for Regulatory Affairs Department. Review of draft guidelines