The Final Gatekeeper for Your Supply Chain.
We don't just find factories. We audit, validate, and authorize final release, acting as your local Engineering & QA Director in Asia.
NPI & CMO Oversight
Front-end manufacturing requires rigorous oversight. We act as your proxy to audit CMOs, manage design transfer, and monitor real-time production within ISO Class 7/8 cleanrooms.
- Design Transfer per 21 CFR 820.30
- DFM & Tooling Supervision
- ISO 13485:2016 On-site Auditing
- Real-time Cleanroom Monitoring
Process Validation (IQ/OQ/PQ)
The core of compliance. We draft and execute comprehensive IQ/OQ/PQ protocols to ensure every manufacturing process is statistically capable and FDA 21 CFR 820 compliant.
- Protocol Drafting & Statistical Rationale
- Equipment Installation Qualification (IQ)
- Operational Limit Testing (OQ)
- Performance Qualification & Pilot Runs (PQ)
Sterilization Management
Managing the highest-risk terminal process. We oversee validation cycles to guarantee sterility assurance levels (SAL) for global market clearance.
- ETO Validation (ISO 11135)
- Gamma Irradiation (ISO 11137)
- Biological Indicator (BI) Testing Oversight
- Routine Sterilization Cycle Review
Quality & Final Release
The final checkpoint before your product leaves Asia. We review Device History Records (DHR) and packaging integrity to authorize final lot release.
- Device History Record (DHR) Review
- Lot Release Authorization
- ISO 11607 Packaging & Aging Verification
- Pre-shipment Inspection (PSI)
Our Engineering Engagement
How we secure your supply chain from audit to release.
Supplier Audit
Evaluating CMO cleanroom and QMS capabilities.
Validation Plan
Drafting Master Validation Plans and IQ/OQ/PQ protocols.
On-site Execution
Supervising pilot runs and sterilization cycles locally.
Final Release
Signing off on DHRs for compliant global shipping.
Secure Your Compliance Pathway
Ensure your Asian supply chain meets uncompromising FDA and MDR standards.
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