Regulatory Affairs Team

The Regulatory Affairs team assists in and performs marketing authorization applications and procedures, whether national, MRP, DCP, CP within the European union, as well as outside of Europe and regardless of the product category (e.g. consolidated and innovative products, generic products, vaccines, tissues etc.)

The team provides strategic regulatory advice and hands on support throughout the product's life cycle and development.

Additionally, the team compiles dossier formats (eCTD), CTA, IMPD, IND, and AMNOG, and manages life-cycle procedures, including variations, PSURs, renewals and xEVMPD/IDMP/SPOR Data handling.

Sub-groups in the team provide

• all services related to compilation and maintenance of product information, CCDS, packaging material and the regulatory review of promotional material, including supporting or providing the function of the German Drug Information Officer (acc. § 74a AMG).
• support in the preparation of eCTD dossier and life cycle management of submissions through the various agencies portals and gateways.

The team is regularly involved in Due Diligences of dossiers.