Be ready when Health Authorities arrive.
We help biopharmaceutical manufacturers prepare for inspections from FDA, EMA, Swissmedic, and other health authorities — and support fast, effective remediation when issues are found.
From sterile production sites to complex CDMO operations, we make sure your site, your systems, and your people are ready.
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)
- Focus on what regulators will see — and where your weaknesses really are
- Strategic, execution-focused remediation, not generic action plans
- Support from first mock audit to final close-out