FDA Inspection Readiness Consulting for Biotech Companies

Be prepared — not just compliant — when the FDA arrives.

We provide FDA inspection readiness consulting that equips biotech and advanced therapy companies to face U.S. and EMA regulators with confidence. From Pre-Approval Inspections (PAIs) to routine audits and 483 remediation, inspections are high-stakes moments that can define your future.

We prepare your teams, systems, and sites through mock inspections, dossier and SOP reviews, and live coaching before, during, and after inspections. With the right experts, FDA readiness becomes more than compliance — it becomes an opportunity to strengthen systems, accelerate approvals, and build lasting trust with regulators and investors.

Why FDA Readiness Matters in Biotech

For clinical-stage and commercializing companies, FDA inspections can define the future.

Insufficient preparation often leads to 483s, warning letters, or even delays to trial or launch timelines.

But with the right experts, inspection readiness becomes an opportunity — to strengthen your systems, align your team, and engage confidently with regulators.

Early, thorough FDA readiness planning protects your credibility, accelerates approvals, and builds lasting trust with regulators and investors.

What We Deliver

Mock FDA inspections (PAI or routine) tailored to your product stage

Gap assessments, SOP and dossier reviews, and data integrity checks

Inspection training for leadership, SMEs, and shopfloor staff

Preparation for formal meetings with the FDA (Type A, B, C)

Regulatory inspection planning, support, and remediation

Remediation strategy after 483s or other observations

Coaching and hands-on support during live inspections

Why Choose GMP Bridge

Do you have experience with FDA, EMA, Swissmedic, ANVISA, and MHRA inspections?

Yes. Our senior partners have been directly involved in numerous inspections from leading agencies worldwide, bringing firsthand knowledge of regulatory expectations and inspection dynamics to every engagement.

How well do you understand U.S. FDA requirements for biotech companies?

We have deep expertise in FDA regulations for biologics, ATMP, and advanced therapies. Our team translates these expectations into clear strategies, helping clients avoid common pitfalls and respond confidently to agency scrutiny.

Who leads your mock inspections and readiness assessments?

Our mock inspections are led by senior auditors with extensive regulatory and operational backgrounds. They know how to ask the right questions — the ones FDA inspectors will ask — ensuring you’re prepared for real-world scenarios.

How do you support clients before, during, and after an inspection?

We provide calm, structured guidance at every stage: preparing your team, supporting you on-site during inspections, and helping you respond effectively to findings. Our goal is to turn regulatory challenges into opportunities to strengthen your quality systems.

Is your GMP setup fit for what’s next?

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