Our team has a proven track record of strengthening the business and scientific aspects of drug product development from concept to commercial launch. We support pharmaceutical and healthcare companies to streamline their R&D teams and processes and to optimize their product portfolio.
With our technical background and hands-on approach, we can help to manage complex development projects and master pharmaceutical and analytical challenges while keeping track of the relevant regulatory aspects for EU and USA. Our Regulatory services cover:
- Elaboration of development concepts and strategies for drug products and corresponding manufacturing processes up to commercialization
- Patent landscape evaluation including-freedom-to-operate analysis
- Establishing and maintaining project reporting structures
- CMC coordination services
- Monitoring of manufacturing campaigns (“man in the plant”)
- Trouble shooting with corresponding gap analysis and root cause assessment
- Preparation and review of technical documents up to the compilation of the entire registration dossier.