07_02Regulatory Affairs

Delegate your regulatory affairs tasks

We not only have the know-how regarding manufacture and quality systems. As your One-Stop-Shop, we have qualified and experienced experts to assist you at any stage of the application process.

On request, we will assess your existing documents or we will compile the required registration documents – based on your or your partner‘s raw data – complete CTDs or individual documents as required. If you don’t have the suitable resources available we can monitor the follow-up as well. Our main focus lies on the EU and MENA markets as well as the US market.

Our service includes:

  • Support during development, e.g. defining suitable specifications
  • Compilation of registration documents, complete CTDs or single modules
  • Compilation of CEP (CoS) applications
  • Preparation of relevant records for registration to responsible authorities (e.g. national Registration Authority, EMA, EDQM, US-FDA)
  • Support for variations
  • Updating and renewals of dossiers
  • Follow-up of deficiency letters