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How to use an interrupted time series to evaluate your digital health product.
How to use a quasi-experimental study to evaluate your digital health product.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The guide, toolkit and further information for GB authorities with responsibility for consumer product safety.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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