Tailored, solution driven, European regulatory strategy consultancy services for (bio)pharmaceutical and biotech industry

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Peifeng CHEN, Ph. D.

Former European deputy therapeutic area head with over 20 years European/European Middle East Africa (EMEA) regional regulatory experience, with a proven ability to lead and manage teams through complex regulatory submissions and Health Authority (HA) interactions. This includes over 15 years European/EMEA regional regulatory lead experience. Worked closely with global multifunctional and country teams in developing and executing regional regulatory strategies. Successfully led regional regulatory activities and HA negotiations for over 50 innovative products in various therapeutic areas of (immuno-)oncology, hematology, metabolic/cardiovascular diseases, immunology, and virology across different stages of development and life-cycle management. Represented Bristol-Meyers-Squibb at Cancer Drug Development Forum. Have strong interests in drug development including pediatric and rare diseases, and innovation.

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Provide tailored European regulatory strategy and Health Authority liaison services, and hands-on regulatory operational support for small molecules, biologics and advanced therapy medicinal products (ATMPs) from early clinical stage, full development to registration and post-authorization. These include (non-exhaustive) :

  • Marketing Authorisation Application: regulatory planning, filing, HA liaison and negotiation, justification for accelerated assessment
  • LCM regulatory strategy
  • (Parallel) scientific advice/protocol assistance/PRIME application
  • Pediatric Investigaton Plan application and maintenance
  • Orphan Drug Designation and maintenance
  • 1 year market exclusivity application
  • Central/national HA engagement/negotiation
  • Oral Explanation/Scientific Advice Group meeting preparation
  • European regulatory document content review
  • Regulatory intellegence, European Public Assessment Report assessments
  • Regulatory guideline assessment
  • EU regulatory strategy from early clinical develoment to post authorisation life cycle management
  • European product information support
  • Address

    Madeliefjeslaan 42
    BE-1970 Wezembeek-Oppem


    Email: peifeng.chen@4orce.eu
    Phone: +32 (496) 19 10 05
    VAT: BE0786400081