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GMP BRIDGE
  • Home
  • Biopharma GMP Consulting
  • Biotech CGT Solutions
  • About us
  • Case Studies
  • Insights
  • FAQs
  • Contact us

CDMO Evaluation, Qualification & Oversight


Select the right partners — and make sure they deliver. 


For biotech companies and ATMP developers, choosing and managing CDMOs is one of the most critical decisions.
At GMP Bridge, we support your full outsourcing journey: from CDMO selection and audits to quality agreements, tech transfer, and ongoing oversight — ensuring you stay in control of GMP, timelines, and product quality. 

 

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.


What We Deliver


  • CDMO scouting, evaluation, and GMP qualification
     
  • 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


  • Experience supporting tech transfer and manufacturing at leading CDMOs
     
  • Consultants who have worked on both the client and CDMO side
     
  • Pragmatic oversight strategies that balance compliance with partnership
     
  • Track record rescuing at-risk outsourcing relationships and preventing delays

     

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

Schedule your discovery call

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