Regulis
Regulis is a UK-based pharmaceutical, biotech, and medical device consulting firm, trading as PharmaLex under Cencora, providing regulatory affairs, pharmacovigilance, clinical development, and market access services to enterprise clients across the UK, Ireland, and Nordics.
- Company typePrivate
- Founded2001
- HeadquartersTring, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Regulis does
Regulis operates a UK-based pharmaceutical, biopharmaceutical, medical device, and cosmetics consulting practice that trades as PharmaLex and is legally constituted as Cencora Global Consulting Services UK Limited, a subsidiary of Cencora (formerly AmerisourceBergen). The firm, headquartered in Tring with additional offices in Redruth and Colchester, provides specialized regulatory affairs, pharmacovigilance, clinical development, market access, CMC, statistics, and quality management/compliance services to pharmaceutical, biotech, and medical device clients across the UK, Ireland, and Nordics. The service portfolio spans the full product lifecycle, from development strategy and clinical trial applications through regulatory submissions, post-approval maintenance, promotional materials compliance, and ongoing patient safety monitoring, supported by a senior team with deep regulatory agency experience and active involvement in industry bodies such as PIPA and the TMF Reference Model Steering Committee.
The practice is organized around five core departments — Research and Development, Statistics and Data Science, Market Access, Patient Safety (Pharmacovigilance), and Regulatory Affairs and CMC — with an additional Quality Management and Compliance function and a dedicated training platform at learn.pharmalex.com. Business is generated primarily through direct enterprise engagement, with senior directors and business development managers owning defined regional territories, supplemented by an active content marketing program (white papers, case studies, webinars, journal articles) and participation in industry conferences.
Revenue mechanics are not publicly disclosed; consulting engagements are scoped on a project basis and pricing is not published. The entity holds ISO 9001 quality management certification and operates without disclosed AI/ML capabilities, relying on senior human expertise rather than automated platforms. As a privately held subsidiary of a Fortune 500 parent, the unit benefits from Cencora's capital and back-office scale but does not disclose standalone revenue, headcount, or financial metrics.
Regulis firmographics
Firmographics- Name
- Regulis
- Legal name
- Cencora Global Consulting Services UK Limited
- Website
- https://regulis.com
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Regulis is a UK-based pharmaceutical, biotech, and medical device consulting firm, trading as PharmaLex under Cencora, providing regulatory affairs, pharmacovigilance, clinical development, and market access services to enterprise clients across the UK, Ireland, and Nordics.
- Ownership category
- akta.pro rank
Regulis industry classification
Industry- Product category
- Pharmaceutical Regulatory and Scientific Consulting
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Management Services (8741)
- akta.pro primary industry
- Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)
- akta.pro secondary industries
- Clinical CROs (Phase I–IV) (HLAGAAAA), Regulatory Compliance Management (RegTech) (BPAEAPAB)
Keywords
Where Regulis is headquartered
LocationHeadquarters
- HQ city
- Tring
- HQ country
- United Kingdom
- HQ region
- Europe
Offices3 records
Markets served
Regulis business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure, Others
Distribution channels1 record
Marketing channels8 records
Regulis product offering
Product offeringCore offering
Regulis provides specialised consulting services to the pharmaceutical, biopharmaceutical, medical device, and cosmetics industries through its PharmaLex service brand. Its offerings cover the full product lifecycle — including regulatory affairs and CMC, pharmacovigilance (patient safety), clinical development, biostatistics and data science, market access, and quality management and compliance — delivered from UK offices with global reach via its parent Cencora.
Product overview
PharmaLex is a service brand within Cencora (formerly AmerisourceBergen) offering specialized consulting services for the pharmaceutical, biotech, and medical device industries. The portfolio encompasses departments including Research and Development, Statistics and Data Science, Market Access, Patient Safety (Pharmacovigilance), and Regulatory Affairs and CMC. Services range from clinical development and toxicological assessments to regulatory writing, TMF services, and compliance training delivered through learn.pharmalex.com.
Differentiator
Problem solved
Functional benefit
Products and services
- Strategic and Scientific Consultancy Cross-functional strategic and scientific advisory engagements for pharmaceutical, biotech, and medical device clients spanning regulatory, clinical, and scientific decision support.
- Innovations to Market End-to-end consulting offering helping pharmaceutical and biotech innovators move new products from development into regulated markets, including development strategy, clinical trial applications, CMC, and regulatory submissions.
- Optimal Patient Access Market access consultancy covering HEOR, market access strategy, pricing and reimbursement, and patient access planning for pharmaceutical and biotech products.
- Business and Portfolio Mergers & Acquisitions Consulting service supporting mergers, acquisitions, and portfolio transactions in the pharmaceutical and biotech industries, including due diligence and integration regulatory support.
- Local Affiliate Services Local affiliate pharmacovigilance and regulatory support services that allow global pharmaceutical companies to maintain compliant local operations across multiple jurisdictions.
- PharmaLex Training (learn.pharmalex.com) Dedicated learning platform (learn.pharmalex.com) offering specialised training courses for pharmaceutical industry professionals across regulatory, pharmacovigilance, clinical, and market access topics.
Companies that use Regulis
Customer profileSegments3 records
Ideal customer profiles3 records
Regulis technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Regulis partnerships and signals
Strategic signalRecent moves5 records
Expansion highlights5 records
Regulis competitors and assessment
Company assessmentEmerging players
- Clinipace Worldwide: Clinipace Worldwide is a mid-size CRO offering clinical research, regulatory affairs, and biostatistics services. As a smaller specialized player, it competes with Regulis in niche pharma consulting engagements.
Direct peers
- Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-size CRO offering clinical development, regulatory affairs, and pharmacovigilance services. It directly competes with Regulis in specialized pharma consulting engagements.
- Syneos Health: Syneos Health is a fully integrated biopharmaceutical solutions organization offering clinical development, regulatory affairs, and pharmacovigilance consulting. It competes directly with Regulis in regulatory and clinical consulting services.
- Medpace: Medpace is a full-service CRO with regulatory affairs, clinical operations, and pharmacovigilance capabilities. It competes with Regulis in providing regulatory and clinical consulting to pharma and biotech companies.
- Charles River Laboratories: Charles River Laboratories provides CRO services including regulatory affairs support, pharmacovigilance, and CMC consulting. It competes with Regulis in regulatory and safety services for pharma and biotech clients.
- Parexel International: Parexel is a global CRO offering regulatory affairs, clinical development, pharmacovigilance, and market access consulting. It directly competes with Regulis/PharmaLex in pharma regulatory consulting and has comparable service breadth across the product lifecycle.
- ICON plc: ICON plc is a global CRO providing clinical development, regulatory affairs, and pharmacovigilance services. It competes directly with Regulis in regulatory consulting and clinical trial services for pharma, biotech, and medical device clients.
- ProPharma Group: ProPharma Group provides regulatory compliance, pharmacovigilance, and quality assurance consulting to pharma and medical device companies. It is one of the most direct specialized competitors to Regulis's regulatory and pharmacovigilance consulting offering.
Broad incumbents
- IQVIA: IQVIA is the world's largest CRO with extensive regulatory affairs, pharmacovigilance, and market access capabilities. As a broader incumbent, it competes with Regulis on enterprise-level regulatory engagements while offering a much wider portfolio including data, technology, and commercial services.
- PPD (Thermo Fisher Scientific): PPD, now part of Thermo Fisher Scientific, is a global CRO with extensive regulatory affairs, clinical development, and pharmacovigilance capabilities. As a broad incumbent, it competes with Regulis on enterprise regulatory engagements.
Market position
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Regulis social profiles
Digital presenceRegulis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Regulis leadership team
Management profileNumber of profiles
Profiles15 records
Regulis funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Regulis 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 Regulis
What does Regulis do?
Regulis provides specialised consulting services to the pharmaceutical, biopharmaceutical, medical device, and cosmetics industries through its PharmaLex service brand. Its offerings cover the full product lifecycle — including regulatory affairs and CMC, pharmacovigilance (patient safety), clinical development, biostatistics and data science, market access, and quality management and compliance — delivered from UK offices with global reach via its parent Cencora.
Is Regulis a public or private company?
Regulis is a private company. It is classified as corporate owned and is currently operating.
When was Regulis founded?
Regulis was founded in 2001. It employs 11 to 50 people.
Where is Regulis based?
Regulis is headquartered in Tring, United Kingdom, in the Europe region.
Who are Regulis's main competitors?
Clinipace Worldwide is listed as an emerging player. Direct peers are Worldwide Clinical Trials, Syneos Health, Medpace, Charles River Laboratories, Parexel International, ICON plc and ProPharma Group. Broad incumbents are IQVIA and PPD (Thermo Fisher Scientific).
Does Regulis have an API?
No public API is recorded for Regulis.
What industry is Regulis in?
Regulis's product category is Pharmaceutical Regulatory and Scientific Consulting. Its primary akta.pro industry code is HLAGAAAH, Pharmacovigilance, Risk Management & Medical Affairs CROs, with a secondary code of HLAGAAAA, Clinical CROs (Phase I–IV). Its NAICS code is 54171 and its SIC code is 8741.