OneSource Regulatory
ProPharma is a UK-registered life sciences professional services firm serving pharmaceutical, biotechnology, and medical device companies with regulatory consulting, CRO, pharmacovigilance, quality compliance, and medical information services across the product lifecycle.
- Company typePrivate
- Founded1999
- HeadquartersLibertyville, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What OneSource Regulatory does
ProPharma, legally registered as ProPharma Group MIS Limited in England and Wales, is a private life sciences professional services firm founded in 1999 that partners with pharmaceutical, biotechnology, and medical device organizations across the full product lifecycle. The company is headquartered in the United Kingdom, with registered offices in London and Exmouth (North Yorkshire mailing address), and claims a global operating footprint spanning FDA, EMA, and other national competent authority jurisdictions. The source data explicitly notes that the queried entity "OneSource Regulatory" does not appear in the provided material; the analysis below reflects ProPharma. ProPharma serves three primary customer segments — pharmaceutical companies, biotechnology companies (with specialized expertise in cell and gene therapy and rare diseases), and medical device/diagnostics manufacturers — through seven integrated service lines: Regulatory Sciences, CRO Services, Quality & Compliance, Pharmacovigilance, Medical Information, FSP Solutions, and Digital Transformation.
OneSource Regulatory firmographics
Firmographics- Name
- OneSource Regulatory
- Legal name
- ProPharma Group MIS Limited
- Website
- https://onesourceregulatory.com
- Company type
- Private
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ProPharma is a UK-registered life sciences professional services firm serving pharmaceutical, biotechnology, and medical device companies with regulatory consulting, CRO, pharmacovigilance, quality compliance, and medical information services across the product lifecycle.
- Ownership category
- akta.pro rank
OneSource Regulatory industry classification
Industry- Product category
- Pharmaceutical Regulatory Consulting
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industry
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)
Keywords
Where OneSource Regulatory is headquartered
LocationHeadquarters
- HQ city
- Libertyville
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
OneSource Regulatory business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Regulatory Sciences Consulting: Comprehensive regulatory consulting services including FDA regulatory consulting, European regulatory development, marketing authorization holder services, regulatory operations, global medical writing, advertising and promotional review, and market access strategy.
- CRO Services: Full-service contract research organization services including clinical operations, site and patient services, biostatistics and programming, and medical device clinical research.
- Quality and Compliance Services: GxP compliance, auditing, computer system validation, inspection readiness, and clinical quality assurance.
- Pharmacovigilance Solutions: Clinical and post-marketing pharmacovigilance, safety systems, signal management, and global ICSR submissions.
- Medical Information Services: Global contact center support, adverse event intake, product complaint handling, and medical communications.
- FSP Solutions: Functional service provider solutions providing professionals as extension of client internal teams, including clinical operations, data sciences, biostatistics, and decentralized clinical trials.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
OneSource Regulatory product offering
Product offeringCore offering
OneSource Regulatory provides regulatory sciences and consulting services that guide pharmaceutical, biotechnology, and medical device clients through the entire product lifecycle, from development and clinical research through approval and post-market activities. The offering combines deep regulatory expertise with tailored solutions to help clients achieve and maintain compliance with global health authority requirements.
Product overview
ProPharma offers a unified platform of professional services spanning the full product lifecycle for biotech, pharmaceutical, and medical device organizations. The core portfolio consists of seven integrated service lines: Regulatory Sciences (FDA, EMA, and global regulatory support), CRO Services (multi-phase clinical development and study execution), Quality & Compliance (pharma consulting and regulation), Pharmacovigilance Solutions (safety monitoring from clinical through post-approval), Medical Information (24/7/365 contact centers with AI-enhanced capabilities), FSP Solutions (flexible functional service provider staffing), and Digital Transformation (data strategy and technology services). These services work together as an end-to-end suite, providing seamless navigation through regulatory, clinical, and compliance challenges from early development to post-market support.
Differentiator
Problem solved
Functional benefit
Products and services
- OneSource Regulatory
- ProPharma Clinical
- ProPharma Compliance
- ProPharma Medical Information
Quantifiable outcome
- SBTi-validated net-zero targets aligned with Net-Zero Standard by 2050
- +1 more outcomes
Companies that use OneSource Regulatory
Customer profileSegments3 records
Ideal customer profiles2 records
OneSource Regulatory technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature3 records
OneSource Regulatory partnerships and signals
Strategic signalScale indicators3 records
Recent moves6 records
Expansion highlights5 records
OneSource Regulatory competitors and assessment
Company assessmentEmerging players
- Certara: Regulatory science software and services company focused on model-informed drug development and regulatory submissions. Emerging competitor in the technology-enabled regulatory space where ProPharma also operates.
- Veeva Systems: Life sciences cloud platform providing regulatory information management (RIM) and clinical software. Represents a technology-led competitive threat to traditional regulatory services players like ProPharma.
Direct peers
- Parexel International: Global CRO with strong regulatory consulting and pharmacovigilance offerings alongside clinical operations. Closely aligned with ProPharma on regulatory strategy, global submissions, and clinical research for biopharma sponsors.
- Worldwide Clinical Trials: Mid-sized global CRO focused on clinical development and supporting services. Comparable to ProPharma in scale and service breadth across CRO, regulatory, and pharmacovigilance offerings.
- PharmaLex (Cencora): Regulatory and compliance consulting firm acquired by Cencora. Directly overlaps with ProPharma on regulatory strategy, submissions, and quality/compliance services for pharma and biotech.
- Medpace: Mid-sized CRO providing clinical research services to biotech and pharma sponsors. Comparable to ProPharma on CRO services and therapeutic area expertise, though with less regulatory consulting breadth.
- ICON plc: Global CRO offering clinical research, regulatory, and consulting services across the full product lifecycle. Directly comparable to ProPharma on CRO services, regulatory consulting, and pharmacovigilance, though at materially larger scale.
Broad incumbents
- IQVIA: Large life sciences services and technology company covering clinical, regulatory, technology, and data analytics. Competes with ProPharma across regulatory consulting, CRO, and pharmacovigilance as part of a much broader portfolio.
- Thermo Fisher Scientific (PPD): Parent of PPD Clinical Research Services, one of the largest global CROs. Overlaps with ProPharma across clinical operations, regulatory consulting, and pharmacovigilance within a much larger corporate parent.
- Charles River Laboratories: Large CRO offering preclinical, clinical, and manufacturing services with regulatory support. Overlaps with ProPharma on CRO services and regulatory consulting across drug and biologics development.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
OneSource Regulatory financial estimates
Financial estimateRevenue estimate
Valuation estimate
OneSource Regulatory leadership team
Management profileNumber of profiles
Profiles2 records
OneSource Regulatory funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
OneSource Regulatory M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about OneSource Regulatory
What does OneSource Regulatory do?
OneSource Regulatory provides regulatory sciences and consulting services that guide pharmaceutical, biotechnology, and medical device clients through the entire product lifecycle, from development and clinical research through approval and post-market activities. The offering combines deep regulatory expertise with tailored solutions to help clients achieve and maintain compliance with global health authority requirements.
Is OneSource Regulatory a public or private company?
OneSource Regulatory is a private company. It is classified as unknown and is currently operating.
When was OneSource Regulatory founded?
OneSource Regulatory was founded in 1999. It employs 11 to 50 people.
Where is OneSource Regulatory based?
OneSource Regulatory is headquartered in Libertyville, United States, in the North America region.
How does OneSource Regulatory make money?
Six revenue lines are on record. Regulatory Sciences Consulting is the primary driver. The others are CRO Services, quality and Compliance Services, pharmacovigilance Solutions, medical Information Services and FSP Solutions.
Who are OneSource Regulatory's main competitors?
Emerging players on record are Certara and Veeva Systems. Direct peers are Parexel International, Worldwide Clinical Trials, PharmaLex (Cencora), Medpace and ICON plc. Broad incumbents are IQVIA, Thermo Fisher Scientific (PPD) and Charles River Laboratories.
Does OneSource Regulatory have an API?
No public API is recorded for OneSource Regulatory.
What industry is OneSource Regulatory in?
OneSource Regulatory's product category is Pharmaceutical Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management). Its NAICS code is 5417 and its SIC code is 8731.