We help biotech startups, clinical teams, and sponsors build fit-for-purpose, inspection-ready quality systems, by delivering customized, lean, and scalable clinical quality and regulatory solutions, enabling YOU to accelerate development, reduce compliance risk, and scale with confidence.

Bespoke Quality & Compliance specializes in supporting emerging biotech and life-science teams with end-to-end clinical quality management, GCP compliance, vendor oversight, and inspection readiness. Our expertise spans QMS development, regulatory submission support, risk-based monitoring, CTN/CTA and IND preparation, eQMS implementation, and quality-by-design frameworks built specifically for fast-growing therapeutics and platform companies.