supportDossier Processing and Lifecycle Management

The regulatory requirements for marketed products are constantly increasing. In this complex environment, you can rely on s4s to handle your entire marketing approval process or parts of it. We evaluate the existing documentation and update it where needed. We prepare dossiers for variations, expert opinions for extensions, format changes from NtA to CTD and from CTD to eCTD and maintain your deficiency notices. On request, we submit your documentation to the regulatory authorities.

 

The services of s4s in the area of dossier processing and lifecycle management include:

  • Literature searches in all relevant databases
  • Consulting in our areas of expertise
  • Processing of marketing approvals (variations, renewals)
  • Preparation of dossiers for variations (quality, non-clinic and clinic)
  • Preparation of expert opinions for renewals (quality, non-clinical and clinical expert statements, addendum to the quality, non-clinical and clinical overview)
  • Preparation of ex ante expert opinions in line with the AMG (Arzneimittelgesetz – German Medicinal Products Act)
  • Format changes from NtA to CTD, and from CTD to eCTD
  • Processing of deficiency notices (quality, non-clinic and clinic)
  • Submittal of the documentation to the regulatory authorities.