Legal Representation

For non-UK biotech and pharmaceutical companies, navigating the UK's clinical trial landscape post-Brexit introduces a critical regulatory hurdle: the mandatory requirement for a UK-based Legal Representative. This role is not just a formality; it is a foundational element for regulatory acceptance and compliance.

We understand that regulatory confidence is critical. As your dedicated Legal Representative, Niche acts not only as your official point of contact with the MHRA, but as a trusted extension of your own organisation — safeguarding compliance, reducing administrative burden, and allowing you to focus on advancing your science.

Compliance you can rely on. Partnership you can trust.

Our robust Quality Management System (QMS) and proven governance frameworks ensure that this critical responsibility is managed with the highest standards of quality and diligence. Don't let regulatory complexity delay your entry into the valuable UK market. Partner with Niche to ensure your clinical trial begins on time and remains compliant throughout its lifecycle.

Conducting clinical research in the UK requires more than regulatory awareness — it demands a trusted local partner. Contact us today to discuss your specific needs and learn how our integrated Legal Representation service can provide a seamless and secure pathway for your clinical development in the UK.

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Frequently Asked Questions
We are not lawyers, but we are clinical trial professionals based in the UK and are well placed to communicate with the MHRA on your behalf.
We conduct regular meetings to stay abreast of study progress and monitor project milestones. We are also ready to respond to the sponsor’s requirements outside the standard meeting schedule.
If your trial is being run in the UK, the MHRA require you to have a legal representative. As an established (25+ years) UK business, we have many contacts in the industry and can provide real-time study support.
We are unable to act as a Legal Representative outside of the UK.

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