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.
Regulatory Consulting Expertise
Led by a former FDA Regulator, KGK’s seasoned regulatory experts are uniquely equipped to provide an insider’s perspective into regulatory operations and the most effective way to navigate a timely and compliant path-to-market. Backed by a vast network of scientific, legal, and regulatory professionals, you’ll receive dedicated support throughout each step of the process.
Leading Clinical Research Since 1997
Clinical Trials Across 40+ Indications
Data Points Collected
Years In Business
Full Time Employees
Supporting Your Business with High-Quality Expertise
As a premium full-service contract research organization, KGK Science provides clinical trial research and regulatory services that meet the highest quality standards, customized to meet the needs of our clients. Contact us today and stake your claim.
As part of our multi-million-dollar research program, KGK has played an important role in helping us confirm the health benefits of our products, especially VitaFiber IMO. Their clinical trial research has contributed to our submission and product acceptance by the world’s top health regulatory agencies. They are a thoroughly professional organization with a strong understanding of businesses’ requirements.
We are so grateful to have been introduced to the professional team at KGK Science. They were patient with our inexperience, assisted us in building a reputable program, created education opportunities with top-notch experts in the field of Dietary Supplements and FDA regulations and guided our models to create truly imaginative studies that will contribute to the scientific body of knowledge in an honorable way.
KGK is responsive and adaptive to our needs, which is important to get a human clinical trial done with good design and within the time frame.