Regulatory Affairs & Quality Assurance
Regulatory Affairs
- Registration applications according to all relevant international procedures (local, DCP, MRP, ANDA)
- Compilation and maintenance of dossiers for national and international application
- Support for customers and cooperation partners for their own filings
- Technical advise during the development process of new drugs
- Determination of international registration strategies
Medical Affairs
- Planning, coordination and quality-management of bioequivalence studies, clinical trials and toxicological investigations
- Qualified Person according to §63/QPPV AMG according to NtA Vol. 9A
- Established Pharmacovigilance System
- Scientific service according to Article 98 of Directive 2001/83/EC
- Coordination of PSUR’s and toxicological & clinical expert opinions
Quality Assurance
- GMP-qualification/ auditing of development partners and manufacturers of API and finished pharmaceuticals
- Product release on customer’s demand
- Qualified Person according to § 15 AMG
- Coordination of required dossier updates
- Organisation of imports from non-EU countries
- Manufacturing license according to § 13 AMG and wholesaler authorisation according to § 52 AMG, GMP certified
Executive Manager :
Dr. Katharina Rönnpagel
Tel. +49 / 40 / 2375 1490
K.Roennpagel@helmag.com