Quality Compliance Inspection Readiness
We prepare your facility, documentation, and team for FDA, EMA, and notified body inspections. This is not a last-minute drill — it is a systematic assessment of your current state against what investigators will expect to see.
- Gap assessments against current FDA enforcement trends
- Mock inspections with realistic investigator scenarios
- Back-room preparation and response strategy
- 483 response drafting and remediation planning
Regulatory Strategy
Before you file, before you manufacture, before you design — we help you understand the regulatory pathway and build compliance into the process from the start.
- Product classification and regulatory pathway determination
- Pre-submission strategy (510(k), PMA, De Novo)
- Design control planning per 21 CFR 820.30
- Clinical and non-clinical evidence strategy
Ongoing Compliance Support
Regulations change. Your quality system must change with them. We provide ongoing advisory support to keep your organization current.
- Regulatory intelligence monitoring
- Change impact assessments
- Annual quality system reviews
- Regulatory authority correspondence management
Regulatory Frameworks
| Framework | Application |
|---|---|
| 21 CFR 210/211 | Pharmaceutical cGMP |
| 21 CFR 820 | Medical Device QSR |
| 21 CFR Part 11 | Electronic Records and Signatures |
| EU MDR 2017/745 | European Medical Device Regulation |
| ISO 13485:2016 | Medical Device QMS |
| ICH Q7/Q9/Q10 | Pharmaceutical Quality System |
| MDSAP | Multi-country Device Auditing |
Why It Matters
An FDA Warning Letter costs more than money. It costs market access, customer confidence, and months of remediation effort. We help you avoid that outcome — not through shortcuts, but through systems that work.