Regulatory activities include
Audit of Dossiers
- Gap Analysis
- Due diligence
Scientific Advices and Referrals
- EU contries / EMA / ITF / FDA
- Writing of briefing doc and slidedecks
- Discussion meeting with HA
CMC writing
- Module 3 and 2.3 (ANDA/IMPD/IND)
- Variation type I and II
- Answer to questions and dossier maintenance
Technical-regulatory intelligence