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 current Good Clinical Practices (cGCP) training
• Additional Pharmacovigilance Services
• Customized literature searches linking to relevant publications
• Monitoring of FDA labeling alerts and assessment of study impact