Regulatory & Compliance Vendors
Regulatory affairs consultancies, promotional review, pharmacovigilance and compliance program services.
26 vendors profiled
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SaaS provider of the LifeSphere platform covering drug safety/pharmacovigilance, regulatory information management, clinical development, and medical affairs for life sciences companies. Serves over 500 clients including pharma companies, CROs, and government health authorities.
- safety case processing (LifeSphere MultiVigilance)
- regulatory information management
- signal detection
- medical information
- clinical data management
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Friedrichsdorf, Germany
PharmaLex is a global specialized services provider for the life sciences industry covering regulatory affairs, scientific affairs, pharmacovigilance, medical information, and quality compliance, operating in over 30 countries.
- medical information services
- pharmacovigilance (end-to-end PV outsourcing)
- regulatory affairs
- development consulting and scientific affairs
- quality management
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Radnor, PA
Certara is a publicly traded biosimulation and drug development services company whose regulatory science business (built on the Synchrogenix consultancy) provides regulatory and medical writing services and AI-enabled writing software such as CoAuthor.
- regulatory writing
- medical writing
- regulatory submissions
- AI-assisted writing software (CoAuthor, Synchrogenix Writer)
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Philadelphia, PA
Global law firm with dedicated pharmaceutical, pharmacy, and FDA regulatory practices, counseling life sciences clients on FDA compliance, drug and device approvals, Hatch-Waxman generic drug matters, recalls, enforcement actions, and False Claims Act litigation.
- FDA regulatory counseling
- pharmaceutical litigation
- Hatch-Waxman / generic drug law
- fraud and abuse / anti-kickback compliance
- recalls and crisis management
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Washington, DC
FDA-focused regulatory and quality consulting firm formed when Validant and Greenleaf Health combined under one global brand. Provides regulatory strategy, product quality and manufacturing compliance, and development consulting delivered by former FDA leaders and industry regulatory professionals.
- FDA regulatory strategy
- quality and manufacturing compliance
- medical device and combination product consulting
- regulatory due diligence
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Milwaukee, WI
Global commercialization services platform for life sciences whose EVERSANA Deploy offering provides outsourced field sales, field reimbursement, and clinical educator teams, alongside integrated launch, market access, agency, and patient services capabilities. Positions itself as a full-service alternative to assembling multiple launch vendors.
- field team deployment
- contract sales
- launch commercialization services
- management consulting
- channel and distribution management
- patient services
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Princeton, NJ
Global regulatory solutions and services company covering the full regulatory value chain — strategy, intelligence, dossiers and submissions, post-approval maintenance, labeling, and artwork change management — for pharma, generics, medical device, biotech, and consumer healthcare companies. Operates across 25 global locations with in-country regulatory affiliates in more than 120 countries.
- regulatory strategy and intelligence
- dossier preparation and submissions
- labeling and artwork management
- post-approval lifecycle maintenance
- regulatory technology
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Tampa, FL
Large U.S. law firm whose pharmaceuticals and biotechnology team advises on FDA regulatory compliance across the product lifecycle — NDAs, biologics, labeling, recalls, post-market obligations — plus life sciences policy, drug pricing, 340B, and PBM matters through its government relations practice.
- FDA regulatory counseling
- life sciences policy and government relations
- drug pricing / IRA and Medicaid policy
- 340B and pharmacy law
- life sciences transactions
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Washington, DC
The largest dedicated FDA law firm in the United States, counseling drug, biologic, device, food, and dietary supplement companies on FDA, DEA, CMS, and FTC matters including new drug development, controlled substances, advertising, and compliance.
- FDA regulatory law
- drug development counseling
- DEA / controlled substances law
- advertising and promotion review
- enforcement defense
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Durham, NC
Global human data science company whose prescription and sales datasets (National Prescription Audit, National Sales Perspectives, LRx longitudinal prescription data, Xponent) are the industry standard for measuring US pharmaceutical demand. Its commercial analytics platform supports HCP targeting, launch tracking, and omnichannel engagement for pharma.
- National Prescription Audit (NPA)
- longitudinal prescription data (LRx)
- national sales data (NSP)
- commercial analytics and HCP targeting
- launch analytics
- specialty pharmacy data integration
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AI-powered pharmaceutical state licensing compliance software and services for manufacturers, wholesale distributors, 3PLs, and pharmacies. Its Intelligence and Management products automate licensing requirement research, applications, renewals, and regulatory surveillance across all U.S. jurisdictions.
- state licensing compliance software
- AI compliance assessments
- license application and renewal services
- regulatory surveillance
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Farmington Hills, MI
Provider of the OneScan cloud platform for pharmaceutical serialization, EPCIS data exchange, and DSCSA compliance, serving manufacturers, wholesale distributors, and pharmacy dispensers. Its Investigator module manages DSCSA exception handling across trading partners.
- DSCSA compliance software
- EPCIS data management
- serialization and aggregation
- exceptions management
- verification router service
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Mount Arlington, NJ
Provider of healthcare practitioner (HCP) and organization (HCO) identity, licensing, and compliance data for the life sciences industry. Its MedProID platform holds 33+ million records sourced from federal, state, and industry authorities and integrates with CRM and MDM systems for license validation and commercial compliance.
- MedProID HCP/HCO licensing data
- state license verification and PDMA/DSCSA compliance
- HCP data enrichment for CRM/MDM
- sanctions and OIG monitoring
- pre-commercial data for launches
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Canton, MI
MMS is a data-focused CRO specializing in regulatory and medical writing, regulatory submissions, biostatistics, and pharmacovigilance for pharmaceutical and biotech sponsors.
- regulatory and medical writing
- CTD/regulatory submissions
- clinical data management
- statistical programming
- pharmacovigilance
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Austin, TX
Oracle's life sciences division develops Argus Safety (Safety One Argus), an industry-standard pharmacovigilance case management platform supporting intake, case processing, signal detection, and global regulatory reporting for drugs, biologics, vaccines, and devices. Widely used by pharma sponsors and CROs for both pre- and post-market safety surveillance.
- safety case management (Argus)
- regulatory reporting (E2B R3, eVAERS, eMDR)
- signal detection
- safety workflow automation
- MedDRA/WHO Drug coding
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Newton, MA
Parexel's Regulatory & Access consulting organization provides regulatory strategy, submissions support, and compliance consulting for biopharmaceutical companies, staffed by more than 1,300 professionals including over 60 former regulators from FDA, MHRA, NMPA, and other agencies.
- regulatory strategy consulting
- FDA/EMA meeting preparation
- regulatory submissions
- market access and HTA consulting
- product safety and manufacturing compliance
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Guildford, United Kingdom
Specialist pharmacovigilance and medical information service provider founded by former drug regulators, offering case processing, signal and risk management, QPPV services, literature monitoring, and PV audits for pharma, biotech, and device companies across more than 100 countries.
- pharmacovigilance case processing
- signal and risk management
- QPPV and local literature monitoring
- medical information
- PV audits and training
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Raleigh, NC
ProPharma is a global provider of medical information, pharmacovigilance, regulatory, and compliance services, answering inquiries from patients and healthcare professionals in over 30 languages from five contact centers worldwide.
- medical information call centers
- pharmacovigilance
- regulatory affairs consulting
- medical writing
- compliance consulting
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London, United Kingdom
Global provider of end-to-end pharmacovigilance services and technology, formed from the combination of Commonwealth Informatics, Bioclinica's drug safety business, and MyMeds&Me. Offers case processing, signal detection, medical information, and an integrated safety technology platform.
- pharmacovigilance outsourcing
- safety technology platform
- signal and risk management
- medical information call center
- PV consulting
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Pleasanton, CA
Quality and regulatory intelligence platform that aggregates and enriches inspection, enforcement, and regulatory data (FDA 483s, EIRs, warning letters, and documents from 16+ global agencies) to help pharma and medtech companies benchmark compliance risk and prepare for inspections.
- FDA inspection intelligence
- enforcement analytics
- inspector profiles
- regulatory surveillance
- compliance benchmarking
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Reno, NV
Supply chain traceability software company whose rfxcel Traceability System provides serialization, DSCSA and global compliance reporting, environmental monitoring, and supply chain visibility for life sciences companies. Acquired by Italian inspection and traceability group Antares Vision in 2021.
- serialization and traceability software
- DSCSA compliance reporting
- global track-and-trace mandates
- environmental monitoring
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Princeton, NJ
Pioneer in pharmaceutical serialization providing enterprise serialization, aggregation, track-and-trace, and brand protection solutions for DSCSA and EU FMD compliance, including proprietary e-Fingerprint digital product authentication. Operates as part of Markem-Imaje within Dover Corporation.
- enterprise serialization (UniSecure)
- aggregation management
- DSCSA and EU FMD compliance
- product authentication / anti-counterfeiting
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Wilmington, MA
Digital supply chain network platform providing serialization and track-and-trace compliance for more than 40 global mandates, including the U.S. Drug Supply Chain Security Act (DSCSA). Its network connects more than 290,000 trading-partner members for exchange of serialized transaction data.
- DSCSA compliance
- serialization data exchange (EPCIS)
- verification router service
- global track-and-trace mandates
- supply chain orchestration
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Frankfurt, Germany
Trilogy Writing & Consulting is a specialty medical writing consultancy producing clinical, regulatory, safety, and medical content for pharmaceutical and biotechnology companies, with offices in Frankfurt, Cambridge (UK), and Durham, NC.
- clinical and regulatory medical writing
- safety writing
- submission documents
- medical writing project management
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Blue Bell, PA
Pharmaceutical support services company providing patient access and hub services, adherence programs, REMS administration, and safety/evidence services for life science companies, with 13 locations across the US, Europe, and Canada.
- patient support and hub services
- benefit verification
- adherence programs
- REMS administration
- nurse support
- safety and evidence services
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Pleasanton, CA
Veeva's regulatory and safety cloud applications: Vault RIM manages global product registrations, regulatory submissions (eCTD publishing), and labeling workflows, while Vault Safety handles adverse event intake, case processing, and safety report submissions. More than 350 life sciences organizations use Vault RIM.
- regulatory information management
- submission publishing (eCTD)
- registration tracking / IDMP
- safety case management
- labeling and quality management
