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.
Fidelio Healthcare Partners

Fidelio Healthcare Partners GmbH & Co. KG
Schlosshof 7
D-82229 Seefeld, Germany

Phone: +49 8152 98 323 – 61
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