Regain control over your external manufacturing.
We help biopharma manufacturers and CDMOs establish, recover, and optimize control over external manufacturing partners — before quality issues threaten supply, compliance, or product launch.
Why CDMO Oversight Matters
- Weak supplier control exposes you to product quality risks, regulatory findings, and supply disruptions.
- CDMOs prioritize their operational efficiency — not your compliance needs — unless properly managed.
- Lack of visibility and oversight often leads to delayed batch releases, repeated deviations, and inspection readiness failures.
- Health authorities expect active, documented oversight of CDMOs and critical suppliers.
What We Deliver
- CDMO selection and qualification support
- Quality agreements review and negotiation
- Supplier audits and ongoing performance monitoring
- Deviations and batch release issue resolution
- CDMO remediation and escalation strategies
- Setup of structured CDMO oversight programs
- KPI design for supplier monitoring
- Audit readiness for CDMO-related inspections
Why Choose GMP Bridge
- Senior consultants with experience in sterile manufacturing and CDMO operations
- Real-world understanding of how CDMOs work — and how to manage them effectively
- Practical, execution-driven support — not reports or frameworks
- We help you regain control over your external partners, fast