Woodley Bioreg

Name

Woodley Bioreg

Legal name

Woodley BioReg Limited

Website

https://woodleybioreg.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

akta.pro secondary industries

GMP Manufacturing Support Services (QA/QMS, validation, documentation) (HLAAAKAH), Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

Keywords

• Regulatory affairs consulting
• Pharmaceutical compliance services
• Biopharmaceutical regulatory strategy
• Medical device certification
• GMP quality assurance

Headquarters

HQ city

Huddersfield

HQ country

United Kingdom

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs Consulting: Project-based consulting engagements providing regulatory affairs, quality assurance, and compliance support for pharmaceutical, biopharmaceutical, and medical device manufacturers throughout product development lifecycle
2. Flexible Resourcing: Flexible resourcing model providing consultants for regulatory and quality support, from 'man in the plant' services to additional project resources
3. Import Services: MIA and WDA holder providing import services for non-EU manufacturers entering the EU and UK markets, including warehousing and distribution

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Woodley BioReg provides scientific advice, regulatory affairs, quality assurance, and consulting services to pharmaceutical, biopharmaceutical, and medical device manufacturers. The firm holds its own GMP licence from the UK's MHRA and supports clients across the full product lifecycle—from preclinical through marketing authorisation submission and post-approval licence maintenance.

Product overview

Woodley BioReg operates as a unified regulatory affairs consultancy organized into three core service divisions—Pharmaceutical, Biopharmaceuticals, and Devices and Diagnostics—supplemented by a dedicated Resource Centre. Each division provides specialized consultancy services spanning the full product lifecycle from discovery through post-market activities, with services including preclinical/nonclinical development, clinical development, manufacturing, marketing authorisation applications/submissions, and licence maintenance. A common Supplementary Services layer provides cross-divisional project management, agency meeting support, and import services. The Resource Centre offers thought leadership and specialized whitepapers. The company holds its own GMP licence from the UK's MHRA, making it unique among UK regulatory consultancies, and operates offices in the UK, Italy, USA, and China with partner groups in South Korea and Poland.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceutical Regulatory Services Regulatory affairs and quality consultancy covering the full pharmaceutical product lifecycle from Target Product Profile definition through preclinical/nonclinical stages, clinical development, licence submission and maintenance.
• Biopharmaceuticals Regulatory Services Expert consultancy specializing in the development and registration of complex biologics, biosimilars, monoclonal antibodies, vaccines, and toxins, navigating the regulatory approval landscape for biopharmaceutical products.
• Devices and Diagnostics Regulatory Services Medical device and IVD regulatory support covering EU MDR, UK Medical Devices Regulations, and US FDA 21 CFR, including certification through notified bodies and post-market surveillance.
• Import Services (MIA and WDA) MIA and WDA holder services for non-EU manufacturers importing to Europe, including QP/RP services, batch testing, warehousing, distribution, and MHRA cGMP accreditation.
• Agency Meetings Support Regulatory agency meeting preparation and facilitation including IND, scientific advice, orphan designation, and pre-submission meetings with FDA, EMA, and PMDA.
• eCTD Publishing and Submissions Electronic Common Technical Document publishing including document assignment, PDF rendering, validation, and NeeS/eCTD submission preparation for EU, UK, and US regulatory authorities.
• Pharmacovigilance and QPPV Services EMA-registered pharmacovigilance support including xEVMPD submissions, QPPV services, case management, PSURs, and PV system compliance.
• Quality Management Systems (QMS) Services QMS development including QA oversight, QP responsibilities, QC testing, and GMP certification support for compliance throughout the product lifecycle.
• Regulatory Audits Regulatory agency audit preparation, self-audits, for-cause audits, system audits, product audits, conformance audits, and regulatory self-audits.
• Project Management Services Programme and project management for biopharmaceutical, pharmaceutical, healthcare, OTC, and medical device products through clinical, development, and licensing stages.

Quantifiable outcome

• Client saved approximately $14 million in study costs and over 12 months in time through strategic use of comparability protocol
• +3 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered minor and core.

• Partner Groups - South KoreaminorStrategic or Co-development PartnerPartner groups located in South Korea providing regional regulatory support and collaboration for clients operating in the Asian market
• Partner Groups - PolandminorStrategic or Co-development PartnerPartner groups located in Poland providing regional regulatory support and collaboration for clients operating in the European market
• Specialist Testing HousescoreImplementation/ SI/ Consulting PartnerCollaborative partnerships with specialist testing houses for laboratory testing services required for full release testing of pharmaceutical products including batch release, identity testing, product quality specification, stability, and storage indication testing. All laboratory testing facilities must hold cGMP accreditation.
• EU and UK Based PV PartnerscoreImplementation/ SI/ Consulting PartnerPartnership with EU and UK based partners to provide pharmacovigilance requirements. PV providers must all be in receipt of cGPV authorisation from an EU Board of Health.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Regulis Consulting: UK-based regulatory affairs consultancy serving pharmaceutical and biopharmaceutical companies. Comparable niche specialist competing for similar clients in EU/UK regulatory affairs.
• ProPharma Group: Regulatory compliance and quality consulting firm serving pharmaceutical, biopharmaceutical, and medical device companies. Competes directly in GMP compliance, quality systems, and regulatory affairs consulting.
• Arriello: Regulatory affairs and compliance consultancy focused on pharma, biopharma, and medical devices. Directly comparable service portfolio including MA submissions, licence maintenance, and EU/UK regulatory strategy.
• Maetrics: Regulatory and quality compliance consultancy for medical devices, pharma, and IVDs. Direct competitor in medical device regulatory services, QMS implementation, and EU MDR transition support.
• PharmaLex (now Cencora): Major regulatory affairs and pharmacovigilance consultancy serving pharma and biopharma. Direct competitor in regulatory strategy, MA submissions, and licence maintenance services for the same client base.
• Voisin Consulting Life Sciences: Specialized regulatory affairs consultancy for pharma, biopharma, and medical devices. Direct peer in CMC, regulatory strategy, and biological product development consulting.

Broad incumbents

• Parexel Regulatory Affairs: Large CRO offering regulatory consulting as part of broader clinical development services. Competes for enterprise pharma regulatory outsourcing deals, though more focused on integrated clinical-regulatory offerings.
• NSF International (Pharma Biotech): Provides regulatory consulting, GMP compliance, and quality systems services to pharma and medical device companies. Broader organisation but directly competes in regulatory affairs and quality consulting.
• ICON plc Regulatory: Global CRO with regulatory and pharmacovigilance services. Larger scale competitor offering similar MA submission, regulatory strategy, and licence maintenance services as part of integrated drug development offerings.
• IQVIA Regulatory Services: Global CRO with comprehensive regulatory affairs and quality compliance services. Broader portfolio including clinical trials but directly competes in regulatory strategy and licence maintenance for large pharma clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key highlights7 records

Customer concentration

• Xx.com/B10WBR
• Facebookfacebook.com/woodleybioreg
• LinkedInlinkedin.com/company/woodley-bioreg

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

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 Woodley Bioreg