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Regulatory Updates

Regulatory updates – bringing you the latest guidance medicines regulation

In the fast-paced world of medicines regulations, our team keeps a close eye on the latest updates and guidance from the regulators. This page serves as a portal for some of the highlights and key guidance, whilst our monthly Regulatory Intelligence Digest pulls together a monthly update that can be delivered straight into your inbox. You can sign up for this free service on this page, and follow us on twitter @boydconsultants to keep up to date with the latest guidance and advice.

If you would like to speak to a member of our regulatory team, feel free to get in touch and we will be happy to help.

Latest Updates

Sign up here for the monthly Regulatory Affairs Digest.

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Regulatory Factsheets

Click on the link below to download our latest factsheet. We will be adding more in the coming months.

Orphan Drug Designation (EU & UK)

Orphan Drug Designation (US)

The Clinical Trials Regulation and the Clinical Trials Information System

Scientific Advice US-FDA



Regulatory Affairs Digest

Below are links to recent issues of our monthly Regulatory Affairs Digest. To sign up and receive these direct to your inbox, complete the form above.

Regulatory Intelligence Digest – December 21

Regulatory Intelligence Digest – November 21

Regulatory Intelligence Digest – October 21

Regulatory Intelligence Digest – July 21

Regulatory Intelligence Digest – June 21

Regulatory Intelligence Digest – May 21