Regulatory Capabilities


RCRI offers comprehensive global regulatory consulting services for biologics, IVDs and medical devices. Our U.S. and international capabilities include but are not limited to services listed below.

U.S. Capabilities

  • Strategic planning
  • Clinical trial regulatory submissions
  • Pre-market notification (510k)
  • Pre-market approval application (PMA)
  • Investigational device exemption (IDE)
  • Investigational new drug (IND)
  • New drug application (NDA)
  • Biologic licensing application (BLA)
  • Master files
  • Combination products
  • Humanitarian device (HUD)
  • Humanitarian device exemption (HDE)
  • Medical device reporting (MDR) and complaint handling
  • Product development protocol (PDP)
  • Labeling
  • Interpretation of standards and guidelines
  • Preparation and representation at FDA advisory panels and regulatory agency meetings
  • Post-market surveillance protocols
  • Registration and licensing
  • Import certificates and registration
  • Expert reports

International Capabilities

  • Strategic international planning
  • Master files
  • Design dossiers
  • Technical documentation and files
  • Expert reports
  • Labeling
  • Interpretation of standards and guidelines
  • Export certificates and registrations
  • Registration and licensing
  • Vigilance reporting
  • Post-market reporting