Regulatory Compliance

In addition to our expertise in preparing and maintaining regulatory documents and submissions that include investigational new drugs and devices (IND/IDE), we offer:

  • Real-time serious adverse event (SAE) monitoring and triage
  • Adverse event (AE) and SAE coding (MeDRA) and analysis and reporting
  • Concomitant medication coding (WHO Drug Dictionary)
  • Site monitoring and auditing, including good clinical practices (GCP) training
  • Additional Pharmacovigilance Services
    • Customized literature searches linking to relevant publications
    • Monitoring of FDA labeling alerts and assessment of study impact