[email protected]

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