Biotech CDMO Oversight Consulting for GMP Compliance & Quality

Select the right partners — and make sure they deliver.

We provide biotech CDMO oversight consulting that helps clinical-stage companies and ATMP developers manage outsourcing without losing control. From CDMO selection and qualification to governance frameworks and ongoing audits, we ensure your external partners deliver GMP compliance, reliable timelines, and consistent product quality.

The wrong CDMO can cost you your clinical program, your product quality, and your investor confidence. Weak oversight often leads to delays, deviations, and inspection failures. That’s why we design oversight models that give you real visibility, structured governance, and proactive communication — so you can scale your outsourcing without scaling your risks. Outsourcing doesn’t mean offloading responsibility.

With GMP Bridge, you stay in control of GMP execution, compliance, and supply chain integrity.

Why CDMO Oversight Is Critical in Biotech

The wrong CDMO can cost you clinical timelines, product quality, and investor confidence.

Lack of control, misaligned expectations, or poor communication often lead to delays, deviations, and regulatory risk.

A robust oversight model ensures you maintain visibility, quality, and compliance — even when production is outsourced.

You need scalable GMP solutions that match your stage, product, and ambition.

What We Deliver

CDMO evaluation and GxP qualifications

Audits and gap assessments tailored to your product type and regulatory path

Definition and negotiation of Quality Agreements and oversight frameworks

Design of CDMO governance processes, KPIs, and escalation models

Ongoing CDMO performance reviews and audit support

Hands-on remediation of critical issues and communication breakdowns

Why Choose GMP Bridge

Do you have experience with tech transfer and manufacturing at CDMOs?

Yes. We’ve supported complex tech transfers, scale-ups, and commercial manufacturing projects at leading global CDMOs, ensuring smooth transitions and regulatory compliance from day one.

Have your consultants worked on both the client and CDMO side?

Absolutely. Our team includes experts who have held leadership roles within CDMOs and biotech sponsors, giving us a balanced perspective to anticipate challenges and foster productive partnerships.

How do you approach CDMO oversight without damaging the relationship?

We focus on pragmatic, risk-based oversight models that protect quality and compliance while respecting CDMO workflows — building trust rather than adding bureaucracy.

Can you help recover at-risk outsourcing relationships?

Yes. We have a proven track record of stabilizing troubled CDMO relationships, resolving deviations, and implementing systems that prevent costly delays and regulatory findings.

Do you provide CDMO scouting and vendor searches for clients?

No. While we have deep knowledge of the CDMO landscape in Europe, Asia, and other markets, we are not a specialized scouting or vendor search firm. Our focus is on helping clients evaluate, qualify, and manage their chosen CDMO partners to ensure compliance, quality, and reliable execution.

Are you in control of your CDMO — or hoping it works out?

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