MDB Pharma Consult CEO
Summary of Experience Solid expertise in Regulatory Affairs gained during 25 years career in Pharmaceutical industry.
Diversified exposure in the following fields:
- Regulatory CMC ,
- EU Pharmaceutical Expert ,
- Management of Global Regulatory team (Worldwide),
- Management of affiliate Regulatory teams,
- Negotiations with Regulatory Authorities (national and EMA),
- Due Diligences (Regulatory aspects),
- Divestments and transfer of Marketing Authorisations,
- Preparation of compendial monographs (USP, Pharm Eur).