Triple-licensed by the boards of medicine, pharmacy, and veterinary medicine
Licensed physicians, pharmacists, nurses, and veterinary professionals evaluate every case.
All calls answered by U.S.-based licensed medical professionals
Round-the-clock coverage so your reporting timeline starts immediately
Your adverse event data is managed through our custom-built validated database, which meets FDA’s 21 CFR Part 11 requirements. We’ve managed over 2 million adverse events using our SafetyNotes system, designed for data security and audit readiness.
SafetyCall utilizes MedDRA and VeDDRA coding to standardize medical events in alignment regulatory requirements for electronic submissions. Regular dictionary updates are scheduled to ensure harmonization with agency and client versioning.
Adverse events happen around-the-clock. Our licensed physicians, pharmacists, pharmacy technicians, nurses, paramedics, EMTs, medical assistants, veterinary technicians and veterinarians are available 24/7 to receive reports, conduct clinical evaluations, and ensure your reporting timelines start immediately. This helps companies meet regulatory deadlines without maintaining full-time night and weekend coverage.
We handle submissions across multiple regulatory agencies—FDA, EPA, CPSC, Health Canada—so you don’t need to track different forms, portals, and requirements for each jurisdiction. This is particularly valuable for companies selling products across multiple categories or countries.
We maintain adverse event records according to regulatory retention requirements (typically 6-10 years depending on product category). When FDA inspections occur, you have immediate access to organized, complete case files that demonstrate your compliance approach and a team of compliance experts ready and willing to assist.
EPA & PMRA Pesticide Incident Reporting
Pesticides and pest control products report adverse incidents to EPA and/or PMRA under FIFRA Section 6(a)(2) & the Pest Control Products Act. We help companies evaluate human and environmental incidents, determine reportability, and submit to EPA and/or PMRA within required timelines.
Learn More About Pesticide Incident ReportingCommercial Household Product Safety
Commercial and household products may be subject to a variety of regulatory reporting and record keeping requirements including EPA, FDA, PMRA or CPSC. SafetyCall is able to support the assessment for reportability and report preparation to ensure compliance with applicable requirements
Learn More About Household Product SafetyPersonal Care Product Safety
Personal care products may fall under cosmetic regulations or consumer product requirements depending on product claims. We help companies determine applicable regulations, evaluate incidents, and manage appropriate reporting channels.
Learn More About Personal Care SafetyOver-the-Counter Drug Safety
We provide medical management and evaluation, determine serious vs. non-serious classification, and can handle FDA submissions within required timelines for OTC drugs.
Learn More About OTC Drug ReportingCVM Veterinary Medicine Expertise
Animal drugs require adverse event reporting to FDA's Center for Veterinary Medicine (CVM). SafetyCall is the largest and most experienced adverse event practice focused on veterinary medicine, providing real-time AE management and pharmacovigilance services for CVM regulated products.
Learn More About Veterinary Product ReportingNavigate Complex CBD Regulations
CBD product adverse event reporting exists in regulatory uncertainty. We help companies document and manage incidents and prepare for evolving federal and state reporting requirements while managing consumer safety concerns.
Learn More About CBD Product SafetyPharmacovigilance Services
Pharmaceutical adverse event management requires specialized medical evaluation and regulatory submissions under 21 CFR 314.80. Our pharmacovigilance officers provide clinical assessment, and expedited reporting for serious unexpected events.
Learn More About Pharmaceutical PharmacovigilanceMDR Timeline Management (5/10/30 Days)
Medical device adverse event reporting follows 21 CFR 803 with three distinct timelines. We help manufacturers, importers, and user facilities determine which timeline applies, evaluate malfunctions, and submit reports to FDA.
Learn More About Medical Device ReportingMoCRA Compliance Specialists
The Modernization of Cosmetics Regulation Act (MoCRA) created first-time serious adverse event reporting requirements for cosmetics. We can help companies navigate 15-day reporting timelines, serious outcome determinations, and the preparation and submission of reports.
Learn More About MoCRA Cosmetic Reporting15-Day DSHEA Reporting Expertise
Dietary supplement manufacturers face adverse event reporting requirements under DSHEA. We can help you evaluate medical events, determine regulatory reportability, submit to FDA or Health Canada within 15 business days, and maintain records for 6 years.
Learn More About Dietary Supplement ReportingStay informed with expert guidance on adverse event reporting, regulatory compliance, and
product safety best practices.
Get answers to common questions about our adverse event management and reporting services
Onboarding typically takes 4 weeks and includes toll-free number setup, call transfer training, customized intake forms, product knowledge transfer, staff training, database configuration, and client portal access. For urgent compliance needs, we will work with you to expedite onboarding.
We provide adverse event management across 12 industries including dietary supplements (DSHEA), cosmetics (MoCRA), medical devices (MDR), prescription drugs, CBD & medical marijuana products, animal health, OTC drugs, consumer products, medical foods, pet foods, personal care, household products, industrial products, and agricultural and pest control products.
Yes. We provide multi-jurisdiction adverse event reporting and record keeping, fulfilling requirements from FDA (United States), Health Canada, EPA, CPSC, and support for CIOMS and ICH E2B format submissions.
We offer several integration options including data exports in CSV or XML formats, API integration, staff training for your customer service and quality teams, and real-time portal access for collaborative case reviews.
In the event of an FDA inspection, SafetyCall is there to help. Our FDA CFR21 Part 11 compliant and validated database serves as your trusted and organized source for all adverse event reports, making it easy to locate and review information quickly. We are there for our clients to retrieve historical records, submission information, and supporting details to answer any questions an inspector may have. Our consistent processes help to demonstrate that everything is handled in a consistent and reliable way. Our Standard Operating Procedures are also available if needed, providing additional transparency into how SafetyCall manages adverse event from start to finish.