4 + 5 + 100 + 5 = 1 unique resource

What this publication includes:


The regulatory and legal framework for Compassionate Use and Expanded Access to regulatory mechanisms worldwide.

In-depth identification and analysis of the framework in North and South America, Europe, Middle East and Asia Pacific.


What’s in the online resource?


With your purchase, you gain access to our online resource enabling you to search for country-specific information. You can buy individual regions or the entire guide.

Inside each regional folder you’ll find our single over-arching document with our guide to all the regulatory agencies, laws, and guidance documents. Everything is cross-referenced so you can easily link to the source documents, vital when you need to provide evidence and validate your regulatory strategy.

Where there are supporting documents and forms to link to, we’ve also downloaded them where possible so you can find them right inside the resource.

Whilst you can’t print out our regional guides, our online resource allows you to place bookmarks and make highlights or notes for your own use. Any supporting documentation that we’ve supplied can be downloaded and printed freely.

The advantage of the online publication is real-time updates as we regularly update content, refresh website links and identify and interpret new regulations. We will provide ‘alerts’ for significant updates that may affect your decision making, investigation or strategy for compassionate use and expanded access.

Can I copy the information?


All information is provided to purchasers and is protected by copyright.

Copying the guide, sharing personal purchases or re-distributing the content is prohibited by law.

Copyright 2019-2023 Sean Turbeville, Ph.D, Medical Affairs Consultancy, San Francisco CA | Site by Expedio