Development and marketing authorisation for medicinal products
We provide long term innovative concepts for developing, expanding and securing your medicinal product markets and products:
- Development of product ideas
- Regulatory strategies: analysis of regulatory options and hurdles
- Clarification of borderline issues
- Evaluation of borderline products and indications
- Assistance with the purchase and sales of dossiers, products and brands
Diapharm expertly guides the product development and entire marketing authorisation process for generics and OTC medicinal products and ensures their marketability:
- Project management from formula development to medicinal products in their finished form for retail sale
- Preparation and coordination of pre-clinical and clinical studies and expert reports
- Preparation of proof of traditional use
- Readability User Testing
- Dossier authoring, marketing authorisation national/MRP/DCP
Our work on behalf of your medicinal product does not finish after being released on the market:
- Batch release pursuant to the German Drug Law (AMG), audits, GMP advising
- Function as a pharmaceutical company as defined by the AMG
- Assuming the responsibilities of qualified person (QP) and qualified person for pharmacovigilance (QPPV), for example
- Set up quality management and pharmacovigilance systems
- Pharmacovigilance (ADR reports, PSURs)
- Change notifications, change management, scientific advice
- Co-ordinate product transfers
- Switches from Rx to OTC (POM to P)
Diapharm will assist you with every phase of your medicinal product. Contact us!
