Venipharm carries out a complete market assessment for every new project of generic product from patent evaluation, regulatory affairs monitoring, analysis of substitutes and competition survey to licensing opportunities.
Venipharm is a recognized expert in development and registration of generic dossiers thanks to more than ten years of experience. We can start collaborating with external partners at any stage, from R&D to compiled registration dossiers, to obtain marketing authorizations as quickly as possible.
With Venipharm you benefit from:
- A comprehensive monitoring of development projects of all pharmaceutical forms: formulation, manufacture process development, ICH stability studies and bioequivalence studies
- A complete assessment of registration dossiers: ASMF, quality part of finished product, pharmacokinetic studies
- A practical expertise in European procedures and national registration in France
- A strategic choice of registration way through DCP, MRP or national procedure
- A post approval life cycle management: variations, amendments, reimbursement and pricing application