Serious Adverse Event Reporting

Full Pharmacovigilance Support

Triaging product complaints for serious adverse event reporting (SAER), reporting to federal health agencies, and patient follow-ups are mandatory requirements and require heavy investment in full-time staff dedicated to those duties. This mandatory requirement may be especially burdensome to nutraceutical or cannabis start-ups.

KGK Science is a one-stop-shop for managing all your SAER needs. With a high-quality Communications Center based in London, Ontario Canada, KGK representatives will handle the intake of all reported events from the U.S. and Canada; facilitating triage of each product complaint/adverse event call with qualified healthcare practitioners who will assess whether it is serious or not, according to regulations.

• Canada-based communication center to receive all incoming reports from Canada and the U.S.
• Triage services to assess the severity of reports and complaints
• Active pharmacovigilance monitoring of sentinel safety signals from product complaints
• Management of post-marketing safety reporting requirements for ensuring compliance
• Proper handling and secure storage of patient-sensitive data
• Statistical analysis of received reports and risk assessment to mine data for safety signals
• Reporting to FDA MedWatch to comply with US FDA SAE reporting requirements
• Confidential database for compiling data and record keeping
• Follow-ups with patients as per regulatory requirements
• Reporting events and reactions to the U.S. FDA or Health Canada and other health authorities
• Quarterly reports on all events, statistically analyzing the post-market data and assessing the need to take regulatory action.