We specialize in CDMO oversight consulting that helps biopharma manufacturers and CDMOs establish, recover, and optimize control over outsourced production. External manufacturing can speed up growth, but without strong governance, it quickly becomes a liability. We ensure your CDMOs operate under GMP standards, protecting supply continuity, compliance, and your product launch.
Every sterility assurance project at GMP Bridge is led by senior consultants with decades of hands-on experience in aseptic manufacturing. Our experts have successfully implemented contamination control strategies and sterility assurance programs in high-throughput biologics and ATMP facilities, consistently reducing contamination events and deviation rates.
We have worked directly with leading CDMOs across Europe and the US, helping clients establish clear quality agreements, improve communication, and resolve recurring issues. Our approach is based on real-world experience, not theory, enabling you to anticipate and prevent common pitfalls in CDMO relationships.
Our recommendations are always practical and tailored to your facility’s realities. For example, we have redesigned environmental monitoring programs and aseptic operator training to fit actual production schedules—leading to measurable improvements in audit outcomes and day-to-day performance.
GMP Bridge delivers actionable solutions and direct support, not just recommendations on paper. We have helped clients recover control over delayed projects, resolve compliance gaps, and implement supplier oversight processes that actually work in daily operations.
Our interventions are designed for speed and impact. We have supported clients in regaining control over critical suppliers and CDMOs within weeks, reducing supply chain risks and restoring confidence with regulators and internal stakeholders.