Bert Spilker & Associates

Bert Spilker & Associates is a specialized pharmaceutical and biotechnology consultancy firm led by Dr. Bert Spilker, a renowned expert in drug development and clinical research. The firm provides strategic advisory services to pharmaceutical companies, biotech startups, and regulatory agencies, focusing on clinical trial design, protocol development, and regulatory submission strategies. Dr. Spilker, who has authored 15 foundational textbooks on drug development, brings decades of experience from leadership roles at PhRMA and major pharmaceutical corporations. The consultancy is particularly noted for its expertise in orphan drug development and navigating complex regulatory landscapes to accelerate the delivery of new medicines to patients.