Article 1
This Regulations has been developed in accordance with the requirements of Drug Administration Law of the People’s Republic of China, Medical Device Regulations and applicable statutes to regulate the overseas inspection of pharmaceuticals & medical devices.
Strategy Consulting
- Market Entry Strategy
- Regulatory Strategy
- Clinical Strategy
- China Localization Strategy
- Hainan Urgent Use Pathway
- Innovation Pathway
- Fast Track Pathway
- Digital Health Consulting
Registration Affairs
- Pre-market Registration
- Modification Registration
- Renewal Registration
- Request for Classification
- Legal Agent Representation
- NMPA Expert Panel Meeting
- NMPA Supplemental Notice
Quality Assurance
- Postmarket Surveillance Compliance (IFU, Label, GSP)
- Adverse Event Reporting
- Recall Handling
- Periodic Risk Evaluation Report
- Annual QMS Self-Inspection Report
- NMPA Inspections & Mock-Audit
- QMS Establishment/Audit/Remediation
- QA Gap Analysis
- Factory Audit
- Unique Device Identifier
Device Testing
- China Local Type Testing
- Device Modification Compliance Testing
- Biocompatibility Testing
- EMC Testing
Clinical Research Organization (CRO)
- Clinical Trials/Research
- Real-World Study
- China CER & MDR CER
- Clinical Evaluation Feasibility Assessment
Customized Training
- China Regulatory Training
- China QMS Training
- China GCP Training
- China Localization Training
- Periodic Regulatory Updates Training
Other Services
- Translation
- Patent & Trademark
- Distributor Evaluation & Audit
- KOL Interview/Consultation
- Investment
- Global regulatory services
