Regulatory Services
- Global Regulatory Strategy
- MDR/IVDR compliance, training and compliance
- Regulatory Submissions and documentation (IND, NDA,BLA, eCTD, 510(k),IDE, PMA)
- Clinical Trial and CRO Coordination
- Vaccine and Biotech product development
- CE Mark and International registrations
- Design Control and Development
- Product registration – Domestic and International
- Risk Management and evaluation
- FDA and Notified Body Liaison
- Usability and Human Factors