R&D Management and Regulatory Services

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.

Our general R&D services cover:

Technical due diligence of pharmaceutical companies with regards to R&D during M&A-projects
Assessment of development organizations and infrastructure and advice for optimization
Establishing R&D management tools, reporting structures, KPIs
Technical and commercial portfolio assessment
Elaboration of proposals for new project initiations
Set-up of a continuous risk-based portfolio management process

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.

back