Bertine Vorstenbosch – de Wijs is a Freelance Regulatory CMC Specialist and CMC Project Manager with more than 15 years of consultancy experience supporting global pharmaceutical and biotechnology companies. Her career began in Organic Chemistry R&D laboratories, after which she transitioned into Regulatory Affairs, a field she continues to enjoy deeply.

Over the past two decades, Bertine has developed extensive expertise in the preparation, review and compilation of CMC documentation across all stages of drug development, from early clinical phases through post‑approval lifecycle management. Her specialties include Drug Master Files (DMFs), Quality Modules 2.3 and 3, regulatory compliance, change control, and regulatory impact assessments. She has supported a wide range of molecule types, including small molecules, peptides, monoclonal antibodies, microbial challenge agents, antibody‑drug conjugates and radiopharmaceuticals, and dosage forms such as tablets, capsules, lyophilized powders, injectables, ointments and oral solutions.

Bertine’s professional background spans roles at Diosynth, Synthon, Kinesis Pharma, Organon / Schering-Plough / MSD, Disphar International, Xendo / ProPharma Group and Oxytone Bioscience / Galenicap, where she contributed to global submissions including IMPDs, INDs, ASMFs, MAAs, NDAs, ANDAs, NDSs and BLAs. Her responsibilities have included regulatory strategy development, compliance reviews, variation and lifecycle submissions, Health Authority response management, and coordination of CMC source documentation. She has prepared CMC documentation for international submissions and managed the Health Authority response process across multiple organizations.

Since 2024, she has operated as an independent consultant under Vorstenbosch Regulatory CMC Support, providing high‑quality CMC regulatory services to clients worldwide. She also contributes to training and mentoring new RA CMC professionals and shares regulatory intelligence with colleagues and clients.

Bertine holds a B.Sc. in Organic Chemistry from HAN University of Applied Sciences and began her scientific career at the Catholic University of Nijmegen. Her combined laboratory, regulatory and project management experience enables her to bridge scientific detail with regulatory expectations, ensuring clear, compliant and regulator‑ready CMC documentation.