We offer the following services:
Clinical research
- Clinical Evidence
- Clinical Strategy
- Clinical Studies
- (CRO) Clinical Research Organization
- Medical Writing
- Clinical Evaluation
- Performance Evaluation
- Clinical Report Writing
- Post-market clinical Follow-up
- Post-marketing Surveillance
Quality management
- QMS ISO 13485
- SOP development / SOP optimization
- QMS for Clinical Trials (GCP/ISO 14155)
- MDSAP
- Internal Audits
- GAP Analysis
- GMP (Good Medical Practice)
Approval / Market Access
- Regulatory strategy
- Technical Documentation
- MDR Compliance
- IVDR Compliance
- FDA Compliance
- NMPA Compliance
- International Markets
- Certificate Withdrawal