Based on extensive hands-on experience in the development of biosimilars, I am able to offer my clients support the following areas:

Project Management

  • Design, review and enforcement of development plans
  • Project control
  • Selection and management of third party service providers
  • Design and review of contracts/agreements
  • Interim project management to overcome (temporary) ressource shortages
  • ...



  • Design and review of development documents
  • Design and review of validation plans and reports
  • Interpretation of data
  • Report writing
  • ...


Regulatory Affairs

  • Preparation for and support of Scientific Advice meeting with Health Authorities (incl. preparation of briefing documents)
  • Design and review of marketing authorisation documents
  • Preparation of responses to deficiency-letters
  • ...


Due Diligence

  • Review of development programs (e.g. for in-licensing considerations)
  • Audits
  • ...


This list does not claim to be complete, so please feel invited to contact me to discuss how I could best fulfil your specific requirements and needs.