Drug Regulatory Affairs
HERMES Drug Regulatory Affairs department employs a highly qualified staff of pharmacists, chemists and pharmaceutical assistants. Our committed regulatory affairs team provides a complete and highly competent registration service for products developed in-house.
This entire service observes the prevailing regulatory requirements and accommodates our customers' requests for special products.
For products developed in-house, we offer:
- Compilation of services chemical-pharmaceutical documentation (Module 3)
- Expert reports on quality (Module 2.3 Overall Quality Summary).
- Implementation of bioequivalence studies with CROs
- Processing of deficiency reports from registration authorities
- Preparation and compilation of advice amendments/variations on quality issues
- Preparation of package insert leaflets and summary of product characteristics according to current provisions of the AMG (Arzneimittelgesetz, German Drug Law)
- Coordination of the external procurement of pharmacological/toxicological and clinical documentation and expert reports
Furthermore, we offer:
- Competent advice on the selection of suitable registration strategies
- Planning, organization and implementation of Mutual Recognition or Decentralized Procedures
- After registration, permanent regulatory life-cycle management for products we manufacture for our customers
- Updating of chemical-pharmaceutical documentation based on the highest level of development
The advantages for our customers are:
- Our regulatory staff is involved in our development projects from the very beginning.
- This early involvement of regulatory expertise in all stages of pharmaceutical development enables target-oriented, quick and cost-effective monitoring of registration projects.
- Permanent regulatory life-cycle management for products which we manufacture for our customers in house after registration has been granted.
We stay up to date with ongoing changes to regulatory provisions by providing continued training for every staff member in internal and external seminars.