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.
Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
We live in a world of measurement and metrics. Running a successful business requires a thorough analysis on the work, sales, and financial results. Of course, identifying and tracking business...
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...
Why You Need a Decentralized Clinical Trials Strategy - Before Disaster Strikes
Imagine having your clinical trial ready to go, or already underway, and overnight the brakes are slammed, bringing your trial to a screeching halt. This was the reality for sponsors around the world...
In May 2022, the IVDD will be repealed by the European Committee, thereby ending the transition period. To ensure you're compliant with IVDR by that date, learn everything you need to know about the...
Battle of the Regulators: Comparing FDA’s Accelerated Approval and EMA’s Conditional Marketing Authorisation
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer various pathways that can expedite the development and review of new therapies to treat serious or...
Roadmap for Successful IVDR Transition, Part II: Technical Documentation & Software
The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching (May 2022). In this blog series, we discuss the final months before the IVDR date of application along with...
CMC Regulatory Dossier Compliance: A GMP Requirement
Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...
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...
FDA’s Breakthrough Therapy Designation vs PRIority MEdicines (PRIME) Application in Europe
What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...
