Regulatory affairs

Managing medicinal product marketing authorisations and preparing and maintaining the documents to go along with them are our speciality. Diapharm has already handled more than 1,500 such dossiers.

From preparing the CTD dossier ...

The field of “regulatory affairs” encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a medicinal product. Dossiers are at the forefront of this process. Diapharm’s regulatory affairs managers work on behalf of pharmaceutical companies to compile information about medicinal products and present it in the form the authorities require. For more than 25 years, clients have been placing their trust in our expertise in preparing and maintaining such dossiers. On behalf of our clients, we compile all information on clinical studies, medical safety and efficacy trials, medicinal product quality, analytical testing, approved use, pharmacovigilance and much more in an (electronic) common technical document, also known as an eCTD dossier.

... and marketing authorisation ...

Regulatory affairs for marketing authorisation procedures

Our regulatory affairs managers advise pharmaceutical companies on how they can launch medicinal products without delays and keep them on the market throughout their life cycle. We evaluate existing documents / dossiers, point out options that make sense from a strategic and regulatory perspective and support scientific consultation with the appropriate authorities. We also manage complete marketing authorisation projects:

  • National marketing authorisation procedure
  • Mutual recognition procedure (MRP)
  • Decentralised procedure (DCP)
  • Centralised procedure (CP)

... to renewal

We stay active on our clients’ behalf, even after their medicinal products have received marketing authorisation. Our drug regulatory affairs managers update existing dossiers to keep them in line with current legal requirements and take care of variations as and when the need arises. We can also take on  direct responsibility for medicinal products depending on the situation and your requirements, acting as information officer, qualified person for pharmacovigilance (QPPV), qualified person (QP) or marketing authorisation holder (MAH).