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.
October 19, 2021
Everything we do today is traceable. The integrity of the data, documents and decisions needs to be defendable and consistent. Electronic Quality Management Systems (eQMS) are an effective way to...
October 13, 2021
Do you really know how to accelerate the approval of your innovative product in Europe? European Expedited Regulatory Programs: The FDA’s incentives for promising new medicines are widely known....
October 11, 2021
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
October 6, 2021
On Thursday, September 30th, FDA announced its user fee rates for fiscal year 2022 for Sponsors using the priority review vouchers (PRVs) for the following: Tropical diseases Material threat medical...
October 5, 2021
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
October 4, 2021
A drug must be safe and effective. Manufacturing of a drug product should consistently yield a predetermined quality. These are the undisputed goals for commercialization of a drug within our...
October 26, 2020
Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution. The European Medicines Agency (EMA) has issued draft guidance on how...
November 11, 2019
All Marketing Authorization Holders (MAH) of medicines for human use are facing what might feel for many, as a new requirement: review their drug products on the possible presence of nitrosamines....
June 27, 2019
We are living through a medical revolution. Advances in gene therapy, cell‑based therapies and tissue engineering offer real hope for patients with a range of debilitating diseases. The FDA, EMA and...