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 !