Services in Regulatory Affairs

10. February 2022

Regulatory Affairs Management

• Regulatory-strategic due diligence review to assess the regulatory status of Marketing Authorisations

• Marketing Authorisation applications or registration applications
  • National Marketing Authorisation procedures
  • Mutual Recognition Procedures (MRP)
  • Decentralised Procedures (DCP)

• Preparation of Marketing Authorsation dossiers
• Application
• Continuous support during the approval process

• Update and reformatting of quality dossiers (NtA to Common Technical Document (CTD or eCTD))

• Life-Cycle-Management
  Preparation and processing of CMC-documentation (CMC=Chemistry, Manufacturing, Control) including communication with supplier, partner and authorities and coordination of required activities

• Surveillance of timelines and submission and of variations

• Preparation and update of product information in accordance with §§ 10 to 12 AMG

• Surveillance of regulatory timelines

• Preparation and timely submission of renewals

• Provision of Information Officer according to § 74a AMG

• Control of manufacturing- and test specifications with regard to compliance with the marketing authorisation

• Performance of Readability User Test
  Via interview-procedure it is tested, if the patient is able to find and understand the information in the package leaflet for proper and safe use the medical drug.

• Preparation of Bridging Reports
  Reference to an already tested patient information leaflet of medicinal products

Upon request, we may represent the Marketing Authorisation Holder for your medicinal product (s), as well as the function as Qualified Person for Pharmacovigilance (§ 63a AMG), Information Officer (§ 74a AMG) and / or Qualified Person (§ 15 AMG).