GMP Inspection Readiness Consulting for Biopharma Companies

Be ready when Health Authorities arrive

We specialize in GMP inspection readiness consulting for biopharmaceutical manufacturers and CDMOs. We prepare your sites for inspections from FDA, EMA, Swissmedic, MHRA, and ANVISA, ensuring not only documents but also systems, facilities, and teams are inspection-ready.

Failed inspections can halt supply, delay product launches, and damage your company’s reputation. Regulators expect more than a binder of SOPs — they expect a risk-based Quality System supported by trained, confident staff at every level. That’s why our approach goes beyond documents: we prepare your operations, shopfloor, and leadership team to engage inspectors with clarity and confidence.

When findings occur, we act fast with remediation strategies that are strategic, sustainable, and regulator-ready, helping you recover credibility and keep your business moving forward.

Why Inspection Readiness Matters

Failed inspections can stop supply, delay product launches, and damage reputation.

FDA, EMA, and Swissmedic expect more than documents — they expect a robust, risk-based Quality System and prepared, confident teams.

Many companies focus only on documents. We prepare your entire operation — including staff, shopfloor, and leadership team.

When findings occur, remediation must be fast, strategic, and sustainable.

What We Deliver

Full inspection readiness assessments (FDA, EMA, ANVISA, MHRA, Swissmedic)

Mock audits simulating real regulatory inspections

Coaching for Quality, Operations, and leadership teams

Preparation of audit rooms, documentation flow, and response strategies

Support for formal FDA meetings (e.g. Type C, post-483, post-warning letter)

Remediation strategy and execution after 483s or major findings

CAPA design, implementation, and effectiveness monitoring

Onsite or remote support during inspections, if needed

Why Choose GMP Bridge

Senior consultants with hands-on inspection experience (FDA, EMA, Swissmedic)

Our team includes senior consultants who have personally led and supported numerous FDA, EMA, and Swissmedic inspections. We know what inspectors look for and how to prepare your team and documentation for success, drawing on real-world experience from high-stakes audits.

Focus on what regulators will see — and where your weaknesses really are

We prioritize the areas that matter most to regulators, identifying true vulnerabilities through targeted gap assessments and mock audits. Our approach ensures you address the issues that could lead to findings, not just surface-level compliance.

Strategic, execution-focused remediation, not generic action plans

GMP Bridge delivers tailored remediation strategies with clear priorities and timelines. We have helped clients resolve 483s and warning letters, close out inspection findings, and implement sustainable improvements that stand up to regulatory scrutiny.

Support from first mock audit to final close-out

We guide you through the entire inspection readiness journey—from initial mock audits and staff coaching to real-time support during inspections and final close-out of findings. Our clients consistently achieve successful outcomes and improved regulatory relationships.

Ready to make sure your site passes its next inspection?

SCHEDULE YOUR CALL