After your product is approved, you may need to amend the conditions of your Marketing Authorization, for instance, when your manufacturing process changes, or just because you need to keep up with scientific and regulatory developments. Bronsing helps you plan for these amendments, whether you need the application for a single or multiple products.
Bronsing Life Science Consultancy:
- helps you prepare, compile, and plan for the variations
- authors new labels
- applies for the variation with relevant authorities (single variations or for larger procedures involving many MAs, i.e. ‘Work Sharing Procedures’)