Inspection Readiness
Mock audits, gap assessments, CAPA acceleration, SME coaching, and day-of-room support. Tailored for FDA, EMA, and Health Canada.
- Mock inspections & storyboards
- GxP documentation remediation
- Audit logistics & war-room setup
Regulatory-grade results without the drama
We help Pharma, Biotech, and MedTech teams build resilient Quality Systems, pass inspections, and move faster—without compromising compliance.
- Inspection readiness (FDA, EMA, Health Canada)
- Annex 1 & contamination control strategy
- 21 CFR Part 11 & CSV/CSA
- Environmental Monitoring & sterility assurance
Trusted by quality-first teams
- Pharma
- Biotech
- MedTech
- CDMOs
- Diagnostics
Services
Clear scope, measurable outcomes, and documentation that stands up to audit.
Sterility Assurance
Annex 1-aligned contamination control strategy, EM program design, aseptic behaviors, and RABS/isolator readiness.
- CCS & risk assessments
- EM trending & excursions
- Media fills & aseptic training
Digital Compliance
21 CFR Part 11 strategy, CSA/CSV, and validation packages that satisfy auditors while enabling speed.
- Part 11 readiness
- IQ/OQ/PQ documentation
- Vendor audits & SOPs
Industries & Modalities
Small-moleculeBiologicsATMPsCombination productsSaMDCDMO
From greenfield facilities to remediation programs, we align with your stage and scale.
Proof & Outcomes
Inspection Pass, Zero 483s
Prepared a site for FDA pre-approval inspection in 8 weeks; established storyboards, closed 27 gaps, and trained SMEs.
EM Program Turnaround
Redesigned EM trending & governance; reduced alert/action excursions by 38% while increasing sampling compliance to 99.5%.
These are representative outcomes; replace with your own case studies and metrics.
Our Approach
- Discovery: Scope, risks, and outcomes.
- Plan: Timeline, owners, deliverables, and RACI.
- Execute: Onsite/remote work with working sessions.
- Document: Audit-ready artifacts and training.
- Transfer: Handover and post-engagement support.
Let’s talk
Tell us about your goals. We’ll reply within one business day with next steps and a proposed time to meet.