The Global Regulatory Framework for Medical Information in the Pharmaceutical Industry

Developed over 3 years by 4 Medical Information experts with global, US, European and South American experience, this website and the accompanying quick reference book will help you navigate the bewildering regulations, laws and codes relevant to medical information.

Regularly updated with new regulations or codes, purchasing a subscription will give you immediate access to the current content, a regular newsletter alerting you to new codes or updates plus a soft-cover book for quick reference.

Consulting this quick reference guide will save you hours trawling through complex, user-unfriendly websites. The extensive links throughout the text gives you immediate access to the source regulations, legal or promotional code documents. Using our expert knowledge, you will know exactly what sections of the laws and regulations apply to medical information.

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Coming Soon!

The Global Guide to Compassionate Use Programs was developed over four years by industry, government, regulatory, operational and pharmacovigilance experts with decades of combined global experience.

This book will help you navigate the complex and often confusing individual country regulations and clearly set forth the formal guidance documents, submission requirements and applications – and clarify the roles and responsibilities of the key parties involved in compassionate use programs including sponsor (manufacturer) led and individual physician requests for access.

Using this comprehensive reference guide will save you valuable resources navigating through and translating various country-specific websites. This compendium of over 60 countries, where there is a validated pathway for compassionate use, contains specific detail on the various regulatory pathways as well as critical internet links that allow you to immediately access source regulation documents, including those dealing with pharmacovigilance and drug labelling requirements.

Regular updates are available that address new or revised legislation which will provide you with the most up-to-date information and ensure compliance for stakeholders that may be involved in compassionate use from industry sponsors, manufacturers, individuals and groups of physicians, specialty service providers and independent consultants.

Purchasing a subscription will give you immediate access to current content, with regular RSS feeds alerting you to updates on a per-country basis.

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Our Experience

Clinical development and commercial support of a broad range of orphan drug products for companies such as:

Onyx Pharmaceuticals
Clovis Oncology
Genzyme – A Sanofi Company
Neuraltus Pharmaceuticals
BioMarin
IBM
Acer Therapeutics
Halozyme
Ultherapy
Vertex Healthcare Services
Chiasma
Rebiotix Microbiota Restoration Therapy
Ocular Therapeutix
Merz
Alkermes
Sunesis
Immunomedics
Amgen
Adverum Biotechnologies
Puma Biotechnology

Developed by: Code Creative LLC