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Regulatory Affairs

Your source for content carefully curated for life science consulting, medical information, pharmacovigilance, and regulatory affairs professionals. ProPharma Group’s subject matter experts regularly share their expertise in the form of blogs, feedback regarding recent guidance and regulations, case studies, industry trends, and more.

Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part II
Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part...
March 25, 2020

Each EU Health Authority has published a wide range of information regarding…

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Regulatory Affairs
Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part I
Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part...
March 23, 2020

Each EU Health Authority has published a wide range of information regarding…

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Regulatory Affairs
Meet the Expert: Niklas Finnberg
Meet the Expert: Niklas Finnberg
February 24, 2020

ProPharma Group has launched a “Meet the Expert” series introducing you to…

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Regulatory Affairs
Meet the Expert: Dr. Borja López Pérez
Meet the Expert: Dr. Borja López Pérez
February 13, 2020

ProPharma Group has launched a “Meet the Expert” series introducing you to…

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Regulatory Affairs
Understanding Responsible Person and Wholesaler Dealers Authorization
Understanding Responsible Person and Wholesaler Dealers Authorization
February 7, 2020

Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders…

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Regulatory Affairs
How to Safely Launch Medical Cannabis Products in Germany
How to Safely Launch Medical Cannabis Products in Germany
January 2, 2020

Over the past few weeks the withdrawal of cannabis products from the…

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Life Science Consulting
Meet the Expert: Tom Oakley
Meet the Expert: Tom Oakley
August 14, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you…

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Regulatory Affairs
Gene and Cellular Therapies: Five Keys to Regulatory Success
Gene and Cellular Therapies: Five Keys to Regulatory Success
June 27, 2019

We are living through a medical revolution. Advances in gene therapy, cell‑based…

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Regulatory Affairs
FDA Issues Final Guidance on Providing Regulatory Submission in Electronic Format – The eCTD Mandate is Coming
FDA Issues Final Guidance on Providing Regulatory Submission in Electronic...
June 16, 2015

On the Blog: Are you prepared for the eCTD Mandate? Learn more…

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Compliance
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