Strategic consulting
- Individual regulatory strategies in Europe for chemical substances, phytotherapeutics, homeopathic remedies and veterinary medicinal products
- Advice on selecting the appropriate marketing authorisation procedure
(national, MRP, DCP, CP)
- Advice and support with compiling a high quality marketing authorisation dossier
- Evaluation of your documents prior to submission to the regulatory authorities
- Support with planning and managing meetings with authorities
(e.g. scientific advice meetings)
- Regulatory due diligence – evaluation of third-party marketing authorisation documents