Regulatory services companies help pharmaceutical, biotechnology and diagnostics organisations meet the requirements governing product development, clinical research, manufacturing and market approval. Their expertise supports organisations from early development planning through to post-market compliance.
This category includes companies working on:
Browse 48 UK life science regulatory services companies below.
Biostatistics, clinical trial simulation and data science services
Exploristics is a Belfast-based provider of biostatistics, data science, and clinical trial simulation software and services to the pharmaceutical, biotechnology, medical diagnostics, and device sectors. The company supports clinical development programmes from early-phase design through to regulatory submission,…
Pharmacovigilance consultancy for clinical and post-marketing drug safety
Drive Phase PV Limited is a UK pharmacovigilance consultancy providing drug safety and device-vigilance services across clinical development and post-marketing settings. Services include PV system design, safety database management, signal detection, risk management plans, QPPV provision, periodic safety reporting,…
Clinical research and investigational medicines development services
Fortrea is a global contract research organisation providing Phase I–IV clinical development, clinical pharmacology, data management, pharmacovigilance and regulatory support to pharmaceutical and biotechnology companies. Its UK operations include a 100-bed clinical research unit at Drapers Yard in Leeds, with an…
Bioanalytical, DMPK and analytical sciences CRO for drug development
Resolian UK is a contract research organisation specialising in bioanalysis, drug metabolism and pharmacokinetics, and analytical sciences services for pharmaceutical and biotechnology clients. Operating from purpose-built laboratories in Fordham, Cambridgeshire and Sandwich, Kent, the company delivers GxP and non-GMP…
Full-service CRO specialising in oncology and early-phase trials
Pivotal CRO is a full-service contract research organisation providing end-to-end clinical development support across all trial phases, from first-in-human to Phase III. The company offers clinical operations, regulatory affairs, data management, biostatistics, medical monitoring, pharmacovigilance, and patient…
Full-service CRO delivering clinical trial and regulatory support services
Optimapharm is a contract research organisation providing clinical trial management and observational study services to pharmaceutical, biotech and medical device companies. The company supports trials from Phase I through Phase IV, offering regulatory affairs, medical writing, clinical monitoring, data management,…
GMP analytical testing and pharmaceutical regulatory services
Broughton Laboratories is a UK contract analytical laboratory based at Coleby House near Skipton, North Yorkshire. It provides GMP-compliant chemical and physical quality-control testing for pharmaceutical products, alongside analytical method development, validation, stability testing and extractables and leachables…
Parenteral drug and nutrition stability testing and analytical services
Biopharma Stability Testing Laboratory is a contract research organisation specialising in extended stability testing of parenteral drug products, biopharmaceuticals, and nutritional formulations. Services are performed to UK NHS Yellow Cover Document, British Pharmacopoeia, and European Pharmacopoeia standards,…
Antimicrobial and biocompatible surface coatings for orthopaedic implants
Accentus Medical is a surface engineering company developing and applying biocompatible and antimicrobial coatings for implantable medical devices, particularly orthopaedic implants. Its technologies include plasma-sprayed titanium and hydroxyapatite coatings that support bone integration, and silver-ion surface…
End-to-end lateral flow immunoassay development and manufacturing
Global Access Diagnostics (GADx) is a contract developer and manufacturer of rapid lateral flow immunoassay tests for human, veterinary, and agricultural applications. Operating as a social enterprise, GADx provides end-to-end diagnostic development services from assay design and antibody development through to…
Full-service CRO for Phase I–IV pharmaceutical and device trials
Clinicology is a contract research organisation providing clinical trial management services to pharmaceutical, biotechnology, and medical device companies. Services span site startup, monitoring, project management, regulatory submissions, patient recruitment, medical monitoring, medical writing, and…
Specialist pharmacovigilance and drug safety services globally
PrimeVigilance is a contract research organisation specialising in pharmacovigilance and medical information services for pharmaceutical, biotechnology and medical device companies. The company delivers clinical safety monitoring, post-marketing surveillance, signal detection, benefit-risk management, literature…
R&D consultancy and laboratory services for life sciences companies
Biophys is a contract research and consultancy organisation supporting biomedical, diagnostic device, and biotechnology companies from early development through to commercialisation. Operating from a Class 2 microbiology laboratory at Cardiff Medicentre, the company provides R&D consultancy, microbiology and cell…
Regulatory affairs, pharmacovigilance and compliance services for life sciences
ProductLife Group is a life sciences consulting and outsourcing company providing regulatory affairs, pharmacovigilance and quality services to pharmaceutical, biotechnology and medical technology organisations. Its teams prepare regulatory submissions, manage product registrations, monitor medicine safety and support…
Generic and branded prescription medicines development and supply
Northumbria Pharma is a pharmaceutical company specialising in the development, manufacture, licensing, and supply of generic and branded prescription medicines across primary and secondary care. Its portfolio spans multiple therapeutic areas including rare diseases, neurology, respiratory, and oncology supportive…
Cell and gene therapy CDMO with integrated consultancy services
eXmoor Pharma is a Bristol-based contract development and manufacturing organisation specialising in cell and gene therapies. Operating from a 65,000 sq ft MHRA-licensed GMP facility, the company provides services spanning process development, viral vector and cell therapy manufacture, fill and finish, and QP release.…
IVD and companion diagnostics regulatory consultancy and CRO
ARC Regulatory is a contract research organisation and regulatory consultancy specialising in in vitro diagnostics and companion diagnostics for precision medicine clinical trials. The company provides regulatory strategy, clinical trial management, quality management, and assay validation services to pharmaceutical…
GMP-certified pharmaceutical testing, regulatory and pharmacovigilance services
Sciom is a pharmaceutical services company providing integrated analytical, regulatory, quality and pharmacovigilance support to life sciences organisations. Operating from an MHRA-approved, GMP-certified facility, its services span analytical method development and validation, QC and microbiology testing, stability…
Full-service CRO specialising in academic and spin-out clinical trials
PHARMExcel is a UK contract research organisation providing full-service clinical trial support across Phases I to IV for academic institutions, NHS bodies, spin-outs and commercial sponsors. Services span protocol design, regulatory affairs, study management, monitoring and grant funding support. The company holds…
Full-service CRO specialising in oncology and rare diseases
Simbec-Orion is a full-service CRO providing Phase I to Phase IV clinical trial services, with specialist expertise in oncology, rare and orphan diseases, and clinical pharmacology. Its Merthyr Tydfil campus houses a 58-bed MHRA-accredited Phase I unit, Seirian Laboratories for central pathology and bioanalysis, IMP…