Clinical to Commercial GMP Readiness Consulting for Biotech & ATMPs

Build GMP systems that grow with your company.

We provide clinical to commercial GMP readiness consulting for biotech and advanced therapy companies navigating the transition from early clinical trials to commercial supply. Our role is to align processes, Quality systems, and documentation with evolving regulatory expectations — without turning compliance into a bottleneck.

Scaling a biotech company is not just about science; it’s about building a GMP foundation that regulators and partners can trust. As you progress from Phase 1 to pivotal trials or prepare for BLA/MAA submission, compliance requirements increase exponentially. Delays in Quality system maturity, manufacturing readiness, or CDMO oversight can stall progress and undermine investor confidence.

That’s why we deliver scalable GMP solutions tailored to your stage, product, and ambition — ensuring that your Quality framework grows in lockstep with your business goals.

Why CDMO Oversight Matters

Scaling a biotech company is not just about science — it is about building a GMP foundation that regulators and partners can trust.

As you move from Phase 1 to pivotal trials or prepare for BLA/MAA submission, compliance expectations increase exponentially.

Delays in Quality system maturity, manufacturing readiness, or CDMO oversight can stall your progress — or damage investor confidence.

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

What We Deliver

GMP readiness roadmaps aligned with your clinical and commercial goals

Scalable Quality systems for early-stage biotech and ATMP developers

Phase-appropriate documentation and process control

GMP gap assessments and action plans

Regulatory inspection planning, support, and remediation

Integration of CMC, manufacturing, and QA strategies

Hands-on execution to ensure milestones are met — not just planned

Why Choose GMP Bridge

Senior consultants with deep biotech and CGT experience

Every engagement at GMP Bridge is led by seasoned consultants with 15–25 years of experience in biotech, cell, and gene therapy (CGT) manufacturing. Our team has worked hands-on in sterile production, complex technology transfers, and regulatory remediation projects, giving you practical solutions grounded in real-world execution — not theory.

Expertise in bridging early-stage science with late-stage GMP

We specialize in helping biotech innovators transition from clinical research to commercial manufacturing. Our consultants understand both the scientific complexity of novel therapies and the regulatory rigor required for late-stage GMP. This allows us to build quality systems and compliance strategies that accelerate growth while satisfying global regulators.

Solutions tailored to your growth path — not off-the-shelf templates

We don’t believe in copy-paste SOPs or generic roadmaps. Each solution is custom-built to fit your company’s unique pipeline, business model, and risk profile. Whether you’re scaling a CGT platform or preparing a biologics facility for an FDA PAI, we design systems that grow with you.

Direct execution — not just advisory presentations

Our consultants don’t just hand over slides. We partner with your team to implement solutions on the shop floor, within QMS workflows, and throughout your operations. From Annex 1 contamination control strategies to cleaning validation programs, we’re there until the solution works.

Trusted by clinical-stage startups and global pharma alike

From VC-backed biotech startups to multinational biopharma manufacturers, GMP Bridge is trusted to solve high-stakes GMP challenges. Our ability to operate at both strategic and execution levels makes us a partner of choice across Europe and North America.

Is your GMP setup fit for what’s next?

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