Regulatory affairs
We supports you in finding the appropriate approval strategy and also in national and EU approval procedures (mutual recognition procedures (MRP), decentralised procedures (DCP)).
During these procedures the regulatory authority reviews the safety, quality and efficacy of a medicinal product. Upon receipt of marketing authorisation, the marketing authorisation holder (MAH) is allowed to market a particular medicinal product in one or more EU Member States. After approval has been granted, our pharmaceutical experts at WESSLING also support MAHs in the lifecycle management of their products and take over the maintenance and updating of documentation (renewals and variations).
Preparation of registration dossiers
A registration dossier contains all the information required by law on a medicinal product. WESSLING takes on this task for producers of medicinal products and prepares this registration dossier. For this purpose, we compile all necessary information on the individual dossier modules in CTD format (common technical document).
We also support you in preparing registration dossiers for investigational medicinal products (IMP).
An overview of our services
- Strategies and support in regulatory matters
- Assistance in national and EU approval procedures (MRP/DCP)
- Preparation of registration dossiers (including IMPD)
- Support in the maintenance and updating of approval documents (variations and renewals)
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