SAVING TIME AND MONEY WITH THE RIGHT STRATEGY
Planning and implementing medicinal product developments (e.g. generics, NCE) with a focus on Europe:
- Analysis of necessary pre-clinical and/or clinical trials
- Contracting trials with established CROs
- Project coordination and monitoring
- Evaluation of pharmaceutical information for your dossier
- Support in seeking a favourable API
- Support and contact with contract manufacturers (API or finished product)
- Analysis of optimal authorisation procedures (MRP, DCP, CP, legal basis)
- Risk/benefit analysis for product sub-licensing
Using our comprehensive network and we can help to plan, prepare and submit your dossier for the following products:
- ATMP (advanced therapy medicinal products – as combination medicinal products, medical devices)
- tissue preparations