The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
Our team's extensive experience in facilitating productive interactions with major regulatory bodies, such as the FDA, EMA, and MHRA, is the foundation of our regulatory strategy. We guide you through the complex requirements for approval, proactively communicating with regulators and addressing their ...
Our team's extensive experience in facilitating productive interactions with major regulatory bodies, such as the FDA, EMA, and MHRA, is the foundation of our regulatory strategy. We guide you through the complex requirements for approval, proactively communicating with regulators and addressing their ...
Regulations can be challenging, with ever-changing rules. For example, the UK Government has recently announced a series of new measures that will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), representing the biggest overhaul in UK clinical trial...
SERVICE LEADERSHIP Laurie Smaldone Alsup SVP Regulatory Science Kim Forbes McKean SVP Björn Carlsson Director NDA Advisory Board Related Reading Target Product Profile MakingSense ofINDs–YourKeyto ClinicalTrials From Data to Dossier: Strategies for Effective Submissions ...
Shelley’s extensive professional background includes more than 19 years of service at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). During her tenure, Shelley served in multiple senior positions, including a role as the UK representative on the European Medicines Agency’s...
Download Multiple HAs Regulatory Intelligence (RI), Device Registration and Authorized Representative Services for SaMDs Download EMAMHRAUS FDA RI Report on Digital Clinical Trial Data Capture System in the US and EU Download
MHRA Post-Transition Period Information, Guidance for Industry and Organizations to follow from 1 January 2021, 01 September 2020 As of 01 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. The transition from the EU allows the UK to offer fully indepe...
(MHRA), the United States Food and Drug Administration (USFDA), and European Medicines Agency(EMA), took proactive steps to support the industry. To accelerate the approval procedure, regularly updated guidelines on flexibility were issued to meet compliance, the routine inspection was postponed, ...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Balversa (erdafitinib) as a monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma (UC). Specifically, the indication covers patients harbouring susceptible ...