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.

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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