Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
April 16, 2025
Approximately 5 minutes
Expert Advisory Pathways for Clinical Trials of Medicines in the UK
Expert Advisory Pathways for Clinical Trials of Medicines in the UK
1. Purpose of expert advice
The UK clinical trials framework recognises that early and well-informed dialogue with regulators is essential for the safe and effective development of medicines. To support sponsors and investigators, the Medicines and Healthcare products Regulatory Agency (MHRA) offers expert advice services covering scientific, regulatory, and procedural aspects of clinical trials for medicines. These services aim to improve trial quality, reduce avoidable delays, and ensure participant safety. Source: Clinical trials for medicines: expert advice
2. Who can seek expert advice
Expert advice is available to a wide range of stakeholders involved in clinical development, including:
- Pharmaceutical and biotechnology companies
- Academic sponsors and investigators
- Small and medium-sized enterprises
- Contract research organisations acting on behalf of sponsors
Advice can be requested at different stages of development, from early exploratory studies to later-phase confirmatory trials. Source: Clinical trials for medicines: expert advice
3. Scope of expert advice
MHRA expert advice may cover topics such as:
- Clinical trial design, endpoints, and statistical considerations
- Use of innovative or adaptive trial methodologies
- Quality and manufacture of investigational medicinal products (IMPs)
- Non-clinical and clinical data requirements to support trial authorisation
- Safety monitoring, pharmacovigilance, and risk mitigation measures
- Interpretation of UK clinical trial legislation and guidance
The scope is flexible and tailored to the specific questions raised by the applicant. Source: Clinical trials for medicines: expert advice
4. Relationship to clinical trial authorisation
Expert advice is non-binding and does not replace the formal process for applying for a Clinical Trial Authorisation (CTA). However, it is intended to inform and strengthen CTA applications by clarifying regulatory expectations in advance. Sponsors are encouraged to reflect the outcomes of expert advice discussions when preparing their CTA submissions. Source: Clinical trials for medicines: expert advice
5. How to request expert advice
Applicants must submit a structured request outlining:
- Background information on the medicinal product and development stage
- Specific questions for which advice is sought
- Relevant supporting documentation
Requests are reviewed by MHRA, and advice may be provided through written responses, meetings, or a combination of both, depending on complexity. Source: Clinical trials for medicines: expert advice
6. Fees and timelines
Expert advice services are subject to regulatory fees, which vary according to the type and scope of advice requested. Timelines for delivery depend on the complexity of the questions and the format of advice but are defined in advance to support development planning. Source: Clinical trials for medicines: expert advice
7. Practical value for sponsors
Engaging with MHRA expert advice can:
- Reduce regulatory uncertainty
- Improve the scientific robustness of trial protocols
- Support compliance with UK clinical trial legislation
- Facilitate smoother review during CTA assessment
Early use of expert advice is particularly valuable for novel therapies, complex trial designs, or first-in-human studies. Source: Clinical trials for medicines: expert advice
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