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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.

COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials
COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage,...
April 1, 2020

As of March 27, 2020 Each health authority within the EU has…

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Ten Tips for Conducting Successful Virtual FDA Meetings in the Era of COVID-19
Ten Tips for Conducting Successful Virtual FDA Meetings in the...
March 31, 2020

The outbreak of COVID-19 (coronavirus) in the United States has significantly impacted…

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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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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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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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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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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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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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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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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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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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