Services

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
• ...

CMC

• 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.