Be prepared — not just compliant — when the FDA arrives.
From pre-approval inspections (PAIs) to routine audits and 483 remediations, FDA inspections are high-stakes events for any biotech company.
At GMP Bridge, we prepare your teams, systems, and site for U.S. regulatory scrutiny — with mock inspections, documentation reviews, and support before, during, and after the inspection.
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.
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)
- Remediation strategy after 483s or other observations
- Coaching and hands-on support during live inspections
Why Choose GMP Bridge
- Senior partners with direct FDA, EMA, Swissmedic, ANVISA and MHRA inspection experience
- Deep understanding of U.S. regulatory expectations for biotech products
- Mock inspections led by auditors who ask the right questions
- Calm, structured support before, during, and after inspections