Bronsing combines 15+ years of experience in EU Regulatory Affairs and well-coordinated, cost-efficient project management with a wide network within the relevant authorities. Throughout every phase of clinical development, Bronsing supports your Market Authorization Application and liaises with regulatory authorities on your behalf.
Strategic advice on questions like:
- Which Marketing Authorization Application procedure should I follow?
- Which Reference Member State should I select if applicable?
- Should I obtain Scientific Advice and when?
- Is my medicinal product eligible for a Pediatric Investigation Plan waiver or deferral?
- When is the best time to apply for an Orphan Medicinal Product Designation?
Bronsing helps you develop a comprehensive regulatory strategy, taking into account the expectations of both the US-FDA and the European Medicines Agency. Each phase in this dynamic process results in concrete deliverables. Find out more about the approach by contacting Bronsing Life Science Consultancy.
Activities and deliverables include:
- Guideline analysis
- Development and Strategy Planning
- Coordination with relevant EU and national authorities
- Rapporteur mapping
- Applications for Marketing Authorization, Variations, Orphan Medicinal Product Designation, Scientific Advice, and Pediatric Investigation Plans
- Authoring of product information, and target product profile