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Regulatory Affairs Blog Posts

February 24, 2021 Regulatory Affairs

Meet the Expert: Colin Wheeler

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

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February 18, 2021 Regulatory Affairs

Brexit: New Regulatory Opportunities in the United Kingdom

As the dust settles on the final Brexit deal, the UK’s Medicines…

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February 17, 2021 Regulatory Affairs

How to Maximize the Value of Cell and Gene Therapy...

Product development is an extremely time consuming and challenging process for any…

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February 16, 2021 Regulatory Affairs

Overcoming High-Risk Situations and Tight Deadlines: How to Successfully Complete...

Much like buying a home as an individual, a company contemplating the…

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February 12, 2021 Regulatory Affairs

How GDUFA II Impacts the Timing and Approval Process for...

Facing several regulatory challenges related to the review of abbreviated new drug…

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January 19, 2021 Regulatory Affairs

Top 9 Failure Points During Nonclinical Development

Our experts share the top nine failure points sponsors may encounter during…

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January 12, 2021 Regulatory Affairs

Stability Testing of New Drug Substances and Products

Our experts explain stability testing, the types of stability testing, and what…

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January 5, 2021 Regulatory Affairs

The Truth Can Hurt – But Hearing It at the...

Hearing the truth about your drug from your regulatory consultant can hurt,…

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