Starodub

Starodub is a specialized regulatory and quality consulting firm serving the life sciences sector from its base in Amsterdam. With a team of approximately 20 employees and a network of experts, it provides end-to-end support for drug and device development, from strategic planning and agency interactions to submission publishing and lean operational improvements. The company operates as a trusted partner for biotechs and pharma companies, aiming to bridge the gap between regulatory requirements and commercial objectives. Its service-based model is validated by client testimonials, particularly in advanced therapy areas like ATMPs.

Integrated regulatory, quality, and operational improvement consultancy services leveraging expertise in EMA/FDA/ICH guidelines, GMP, Lean methodologies, and a network of specialized experts.

Operates in a fragmented market competing with large full-service CROs (e.g., IQVIA, Parexel) that offer regulatory consulting, and numerous small boutique firms and independent consultants. Differentiates through a combined focus on strategic regulatory affairs and hands-on operational/quality improvement, with specific cited expertise in complex areas like CAR-T therapy development.