Regulatory Sciences
February 18, 2021
Brexit: New Regulatory Opportunities in the United Kingdom
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...
Regulatory Sciences
February 16, 2021
Overcoming High-Risk Situations and Tight Deadlines: How to Successfully Complete Due Diligence
Much like buying a home as an individual, a company contemplating the acquisition of a new product or business requires a lot of research and fact checking. In both situations, it is critical for the...
ANDA
FDA
February 12, 2021
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
Life Science Consulting
January 28, 2021
Three Things 2021 Has in Store for Pharmaceuticals
Now that we have wrapped up the year 2020, it’s important to look ahead and prepare for upcoming regulatory deadlines. It is essential to address these changes and develop a plan, albeit nimble as...
Meet the Expert
Life Science Consulting
January 21, 2021
Meet the Expert: Eric Good, PhD
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...