SafetyCall

What SafetyCall does

SafetyCall International, LLC is a privately held, multidisciplinary healthcare practice headquartered in Bloomington, Minnesota, founded in 2004 as the corporate successor to the Minnesota Regional Poison Center and Hazard Information Services (which traced back to 1982). The firm provides 24/7 adverse event management, post-market surveillance, pharmacovigilance, and regulatory compliance services to more than 250 manufacturers across approximately 15 regulated industries—including prescription drugs, over-the-counter medications, dietary supplements, cosmetics, animal health and veterinary products, consumer products, consumer medical devices, agricultural chemicals and pesticides, CBD, medical cannabis, institutional products, and industrial chemicals. The company is triple-licensed by the US Boards of Medicine, Pharmacy, and Veterinary Medicine and serves as a recognized authority consulted by the FDA, EPA, and CPSC on product safety matters. It also operates Pet Poison Helpline, a 24/7 animal poison control service, as a wholly-owned division.

The firm's technology platform is built around two proprietary tools: SafetyNotes™, a case management application that documents caller interactions and adverse event data into a single centralized database, and SafetySearch™, a web-based search engine that lets clients retrieve incident data flagged for potential TSCA Section 8(c) and 8(e) reporting. SafetyCall integrates with the PV Works pharmacovigilance database (hosted by Ennov) to support FDA electronic submissions through the FDA Electronic Submissions Gateway. Service delivery is anchored by a US-based 24/7 medical contact center that handles consumer and veterinary inquiries by telephone, email, and letter, with all communications logged into SafetyNotes™ for regulatory-grade documentation and auditability.

SafetyCall's revenue model combines recurring enterprise subscriptions for adverse event management and managed regulatory compliance services with project-based professional services engagements for pre-market hazard assessments, manufacturing breach safety impact assessments, clinical toxicology evaluations, regulatory submissions, and expert witness testimony. Pricing is quote-based and tailored to client regulatory requirements, industry vertical, and service scope, with annual billing cycles as the standard. Go-to-market is direct enterprise field sales supported by dedicated client liaisons across the firm's 12-15 served industries; distribution is concentrated in the US and Canada, with the firm explicitly claiming cross-border regulatory coverage of FDA, EPA, CPSC, Health Canada, and PMRA. The firm employs 300+ staff (across SafetyCall and Pet Poison Helpline) working remotely across 26 US states.

Name

SafetyCall

Legal name

SafetyCall International, LLC

Website

https://safetycall.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

251–500 employees

Short description

SafetyCall International is a privately held, triple-licensed healthcare practice that provides 24/7 adverse event management, pharmacovigilance, and regulatory compliance services to more than 250 manufacturers across approximately 15 regulated industries, including pharmaceuticals, cosmetics, dietary supplements, animal health, and consumer products.

Ownership category

akta.pro rank

Product category

Pharmacovigilance & Adverse Event Management Services

SIC

Services-Health Services (8000)

akta.pro primary industry

Safety & Medical Contact Centers (AE Intake/Call Centers) (HLAGALAI)

akta.pro secondary industries

Pharmacovigilance, Safety Signal Management & Risk Minimization (HLAJADAH), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), Safety/Pharmacovigilance (PV) & Clinical Safety Systems (HLACAOAH)

Keywords

• Adverse event management
• Pharmacovigilance services
• Post-market surveillance
• Regulatory compliance reporting
• Medical contact center

Headquarters

HQ city

Bloomington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Adverse Event Management Services: Ongoing 24/7 management, documentation and assessment of adverse events for manufacturers across multiple regulated industries. Services include case intake, clinical review, regulatory reporting to FDA, EPA, CPSC, and Health Canada.
2. Consulting Services: Product safety consulting including pre-market hazard assessments, ingredient safety evaluations, manufacturing breach safety impact assessments, clinical toxicology evaluations, regulatory submissions, and expert witness testimony.
3. Trend Analysis & Benchmarking: Aggregate data interpretation and trend analysis services helping clients understand ongoing safety surveillance experience, benchmark product safety profiles against competitors.
4. Regulatory Compliance Services: Assistance with mandatory adverse event reporting responsibilities to FDA, EPA, CPSC, and Health Canada including preparation of FDA Form 3500A, PADER, and other regulatory submissions.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

SafetyCall International is a healthcare practice that provides 24/7 adverse event intake, documentation, clinical assessment, and regulatory reporting services for manufacturers across 15+ regulated industries, including prescription drugs, OTC drugs, dietary supplements, cosmetics, animal health, medical devices, ag-chem/pesticides, consumer products, and industrial chemicals. Its service suite covers pharmacovigilance, pharmacovigilance submissions to the FDA Electronic Submissions Gateway, FIFRA/TSCA/CPSC/MoCRA/DSHEA compliance, trend analysis and benchmarking, and product-safety consulting. Underpinning the offering is the proprietary SafetyNotes™ case management platform and the SafetySearch™ regulatory data retrieval engine.

Product overview

SafetyCall International operates as a multidisciplinary healthcare practice providing adverse event management and post-market surveillance services. The company's core technology platform consists of proprietary software systems: SafetyNotes (case management application for documenting caller interactions and adverse event data) and SafetySearch (web-based search engine for regulatory reporting data retrieval). Service offerings include Adverse Event Reporting & Medical Information, Regulatory Compliance Services, Pharmacovigilance, 24/7 Medical Call Center, Trend Analysis & Benchmarking Review, and Consulting Services. The company also operates Pet Poison Helpline as a separate 24/7 animal poison control division. Services span 15 industries including prescription drugs, dietary supplements, OTC drugs, cosmetics, animal health, consumer products, medical devices, agricultural chemicals, CBD, and industrial chemicals, covering regulatory requirements in the US (FDA, EPA, CPSC) and Canada (Health Canada, PMRA).

Differentiator

Problem solved

Functional benefit

Brands

• Pet Poison Helpline: A 24/7 international animal poison control service for veterinarians and pet owners, operated as a division of SafetyCall International

Products and services

• Adverse Event Reporting & Medical Information Services 24/7 intake, documentation, clinical assessment, and regulatory reporting of adverse events for manufacturers across multiple regulated industries. Includes case intake, clinical review, and mandatory reporting to the FDA, EPA, CPSC, and Health Canada for enterprise manufacturer clients.
• Regulatory Compliance Services Expert assistance with compliance obligations across FIFRA, TSCA, FDA (dietary supplements, OTC drugs, NDAs/ANDAs, medical devices), EPA, Health Canada, PMRA, CPSC, and Canadian regulations. Includes preparation and submission of FDA Form 3500A, PADER, and other mandatory filings for manufacturer clients.
• Pharmacovigilance Services Collection, detection, assessment, monitoring, and reporting of adverse effects for pharmaceutical and biological products. Includes case documentation, storage, and support for FDA electronic submissions via the PV Works database (Ennov) integration and the FDA Electronic Submissions Gateway.
• 24/7 Medical Call Center / Consumer Care Center US-based 24/7 contact center handling consumer inquiries and medical information requests via telephone, email, and letter on behalf of manufacturer clients. All interactions are tracked in the SafetyNotes database with customizable reporting and integration into clients' post-market surveillance programs.
• Trend Analysis & Benchmarking Review Aggregate data interpretation and trend analysis supporting ongoing safety surveillance for clients, including normalized incidence rates, tracking of expected rates, sentinel event identification, and benchmarking of product safety profiles against competitors and across product lines.
• Consulting Services Product safety consulting including pre-market hazard assessments, manufacturing quality assurance, ingredient and clinical toxicology evaluations, manufacturing breach safety impact assessments, in-market surveillance, packaging and labeling reviews, regulatory submissions, Health Hazard Evaluations, and expert witness testimony for manufacturer clients.
• SafetyNotes™ Case Management Software Proprietary software application supporting documentation of interactions with callers, collection of adverse event data, and management of post-market surveillance case details for SafetyCall's clients. Underpins the firm's service delivery and provides the audit trail for regulatory submissions.
• SafetySearch™ Regulatory Data Search Engine Proprietary web-based search engine that enables SafetyCall clients to retrieve data on incidents flagged for potential TSCA 8(c) or 8(e) reporting purposes and other regulatory follow-up. Built into the firm's managed-services offering for industrial-chemical and other regulated-industry clients.
• Pet Poison Helpline 24/7 international animal poison control service for veterinarians and pet owners, operated as a wholly owned division of SafetyCall International to support the firm's veterinary and animal-health practice lines.

Quantifiable outcome

• More than 4,000,000 cases managed with positive impact on product safety
• +2 more outcomes

Named customers15 records

Segments10 records

Ideal customer profiles7 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• National Animal Supplement Council (NASC)coreStrategic or Co-development PartnerSafetyCall International is a preferred supplier of the National Animal Supplement Council, having been pre-qualified by NASC to provide adverse event management services to primary suppliers in the animal health supplement industry.
• University of Minnesota College of PharmacycoreStrategic or Co-development PartnerFormal academic affiliation with University of Minnesota College of Pharmacy. Multiple partners and staff hold full and adjunct faculty appointments, teach courses in Clinical Toxicology, Addiction Medicine, Toxinology, and Herbal Medicinal Therapeutic Agents. Company fully funded clinical residencies for pharmacists and veterinarians in partnership with the university.
• University of Minnesota College of Veterinary MedicinecoreStrategic or Co-development PartnerFaculty appointments at University of Minnesota College of Veterinary Medicine where team-teaches Veterinary Toxicology as part of core curriculum and participates in population medicine courses. Formal clerkships and clinical rotations offered to veterinary students.
• Regions HospitalcoreStrategic or Co-development PartnerPartnership with Regions Hospital, a teaching hospital and Level 1 Trauma Center in St. Paul, MN, for fully funded clinical residencies for pharmacists (7) and veterinarians (2) in clinical toxicology.
• Pet Poison HelplinecoreOthersPet Poison Helpline is a division of SafetyCall International, operating as a 24/7 international animal poison control service for veterinarians and pet owners. Same leadership, same location, complementary mission.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• ProPharma Group: ProPharma Group provides pharmacovigilance, regulatory affairs, medical information, and product safety consulting services to pharmaceutical and medical device manufacturers. It competes directly with SafetyCall across the AE intake, regulatory reporting, and consulting stack.
• ArisGlobal: ArisGlobal provides LifeSphere Safety, a unified pharmacovigilance and safety case management platform used by many of the same manufacturers SafetyCall serves. It is a direct competitor at the intersection of PV technology and managed safety services.

Broad incumbents

• PPD (Thermo Fisher Scientific): PPD is a top-5 global CRO with a dedicated pharmacovigilance and safety services practice offering case processing, aggregate reporting, and risk management. Comparable to SafetyCall in PV/regulatory reporting but serves as a much broader drug development partner.
• IQVIA: IQVIA operates one of the largest safety and pharmacovigilance service lines globally, including AE case processing, signal detection, and regulatory submissions. Overlaps with SafetyCall's PV and regulatory compliance offerings but at a far larger, multi-jurisdictional scale.
• Parexel International: Parexel is a global CRO with a dedicated pharmacovigilance, risk management, and regulatory compliance practice. Comparable to SafetyCall in AE reporting and regulatory services, though delivered as part of a full clinical development portfolio.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized global CRO with a pharmacovigilance and safety surveillance offering comparable in scope to SafetyCall's PV services, though delivered as part of broader clinical operations.
• ICON plc: ICON is a global CRO with a dedicated pharmacovigilance and regulatory affairs group offering AE case processing, aggregate reporting, and benefit-risk assessments. Comparable to SafetyCall in PV service lines though delivered at global CRO scale.

Others

• Veeva Systems: Veeva's Vault Safety platform handles adverse event case management, intake, and regulatory submissions for life sciences customers. Veeva is an enabling technology peer rather than a service competitor, but its SaaS model competes with SafetyCall's SafetyNotes platform for the technology layer.
• Oracle Health Sciences (Clinical One / Argus Safety): Oracle's Argus Safety is the dominant enterprise pharmacovigilance platform used by many SafetyCall clients for ICSR management and electronic submissions. Oracle is an enabling technology peer and infrastructure layer for the same regulatory workflow SafetyCall operates in.
• BioTelemetry / ERT (now Clario): Clario provides endpoint technology and safety data services for clinical trials and post-market studies, including cardiac safety and adverse event capture infrastructure used by pharma manufacturers—adjacent technology provider serving SafetyCall's end customers.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/safetycall
• Facebookfacebook.com/SafetyCallInternational
• LinkedInlinkedin.com/company/safetycall-international

Revenue estimate

Valuation estimate

Number of profiles

Profiles20 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SafetyCall