MY EXPERIENCE

  • Over 20 years of experience in nonclinical drug development/toxicology and 10 years of experience in services in early drug development (consultancy, operational support) with clients ranging from start-up companies to big pharma.

  • Over 10 years of experience with project management, program management, and line management.

  • Understanding of drug development processes in combination with knowledge of ICH/GxP guidelines and regulatory requirements.


Based on the above indicated knowledge and experience, I can offer the following services to your development projects:

 

  • Overall nonclinical consultancy for PK/TK, safety pharmacology and toxicology studies.

  • GAP analyses and Due Diligences.

  • Preparing nonclinical drug development plans.

  • Outsourcing and monitoring of nonclinical development programs as a sponsor representative, including CRO selection, protocol design, in-life monitoring, issue management, reporting and review.

  • Taking responsibility for the scientific and regulatory soundness of the project.

  • Troubleshooting within projects on nonclinical (and related) CMC aspects.

  • Writing/contributing to nonclinical documents for regulatory submissions, e.g. nonclinical reports, nonclinical overviews, summaries and tables (INDs), contributions to Investigator’s Brochures (IBs) and IMPDs, etc.

  • Contributing to writing of briefing packages to support Scientific Advice meetings, and participate in such meetings.


Your project is in good hands with me !

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