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ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Compliance FDA

April 22, 2023

The Importance of Responding to FDA 483 Observations

This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...

FDA Life Science Consulting

April 21, 2023

FDA Form 483: Common Pitfalls You Can Avoid

This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...

Regulatory Sciences Promotional Review

April 17, 2023

Who’s Watching? Why You Should Care About Global Promotional Material Review

Recently, there have been two notable cases regarding pharmaceutical advertising code violations based on LinkedIn content. It was announced that Danish drugmaker Novo Nordisk has been suspended by...

EMA EU

April 13, 2023

EMA’s Regulatory Science Strategy to 2025 is on Track

Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...

Regulatory Sciences

April 4, 2023

How to Maximize the Value of Cell and Gene Therapy Products: 5 Tips for Success

This article has been updated since its original publication date. Product development is an extremely time consuming and challenging process for any pharmaceutical, biotechnology, or medical device,...

Quality & Compliance FDA

April 4, 2023

15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

This article has been updated since its original publication date. Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have...

MHRA UK

March 27, 2023

The Future of UK Clinical Research Delivery

ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades. Lord O’Shaughnessy Clinical Trial...

Regulatory Sciences

November 2, 2022

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...

Regulatory Sciences

October 25, 2022

FDA Accelerated Approval Pathway: A Potential Missed Opportunity for Sponsors

The accelerated approval provisions of FDASIA in section 506(c) of the FD&C Act provide that FDA may grant accelerated approval to: . . . a product for a serious or life-threatening disease or...

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