REGINTEL LIMITED
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Regintel Limited is a specialist consultancy that assists non‑EU companies and research organisations navigate the complex regulatory landscape of clinical research and data protection within the European Union and the United Kingdom. Founded in 2003 by former pharmaceutical scientist Breffni Martin, the firm has supported more than 240 clinical trials and over a hundred GDPR‑related studies, working with major pharma players such as Novartis and AbbVie as well as emerging US‑based start‑ups.
The company’s core offering spans regulatory advice and intelligence for EU market access, legal‑representative services under the Clinical Trial Directive and the UK Medicines Act, and comprehensive data‑protection support—including DPO contracts, GDPR gap analyses, impact assessments and training tailored to clinical research. Regintel also provides pharmacovigilance representation, marketing‑authorisation holder services, orphan‑drug sponsorship, and a suite of qualified‑person services for import, certification and labelling. Through a network of partner firms it delivers electronic submissions, medical writing and study‑development assistance.
Regintel operates from multiple establishments across the United Kingdom and the European Union, positioning it to offer seamless, cross‑border support to clients seeking regulatory compliance and market entry throughout Europe.