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Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The information clients, principal designers, principal contractors and accountable persons need to keep.
Learn how the Government Digital Service is monitoring accessibility under the Public Sector Bodies (Websites and Mobile Applications) (No.2) Accessibility Regulations 2018.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to apply for a full or partial completion certificate after building work on a higher-risk building has been completed.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
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