The United Kingdom is a booming and highly innovative market for pharmaceuticals, medical devices, and biotech, driven by strong demand for advanced healthcare technologies and a world-leading life sciences ecosystem.
Post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) independently oversees the regulation of medicines, medical devices, and other health products in Great Britain and Northern Ireland, with distinct pathways including national procedures and recognition routes. The MHRA is known for its rigorous yet innovative approach and offers flexible options such as the Centralised Procedure (via EMA for Northern Ireland), National Procedure (NP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and innovative access schemes. Medwisdom LifeScience provides tailored, expert Regulatory Affairs support to navigate these complexities, select the optimal regulatory pathway, and deliver efficient market authorizations, compliance, and long-term success in the UK market.
Get UK Compliance Support
UKCA marking support, conformity assessment, MHRA registration, vigilance reporting, and compliance with UK MDR 2002 (as amended).
End-to-end clinical trial support, MHRA CTA submissions, site management, monitoring, and compliance with UK clinical trial regulations.
Statistical planning, data management, analysis, and reporting for clinical studies and regulatory submissions to MHRA.
UK QPPV/local contact person services, PSMF setup, adverse event reporting, signal detection, and risk management plans.
Preparation and submission of PSURs/PBRERs, DSURs, RMPs, and other periodic safety update reports to the MHRA.
Development, review, and update of SmPC, PIL, and labeling in line with MHRA readability and UK-specific requirements.
Strategic regulatory consulting, pathway selection (NP, DCP, MRP, ILF), MHRA liaison, and up-to-date intelligence on UK post-Brexit regulations.
Partner with Medwisdom for expert, tailored, and compliant regulatory support in the United Kingdom — from pathway selection and MHRA submissions to pharmacovigilance, clinical operations, and long-term market success.
Contact Our UK Regulatory Experts