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 markets.

Our service includes:

  • Support during development, e.g. defining suitable specifications
  • Gap analysis of existing dossiers
  • Creation of approval documents, complete Common Technical Documents (CTD) or individual modules
  • Assistance with the CEP creation
  • Preparation of approval-relevant documents for submission to the regulatory authorities (e.g. national approval authorities, EMA, EDQM)
  • Support for change notifications
  • Implementation of dossier updates and renewals
  • Complaints processing
  • Support in creating and updating product information
  • Correspondence with the regulatory authorities

Your advantages:

  • Competent support around the approval dossier and the approval maintenance
  • Lifecycle management according to current legal regulations
  • Track deadlines and timelines