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.
Quality & Compliance
In January 2020, FDA published a guidance document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing...
Regulatory Sciences
Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After...
Quality & Compliance
The implementation of a robust Quality Management System (QMS) is a key success factor for clinical development with the goal of reaching marketing authorization. As important as your QMS is during...
The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...
Quality & Compliance
In early 2020, while COVID-19 was wreaking havoc on public health and safety, the FDA took the unprecedented step of postponing domestic and foreign inspections. The FDA’s risk-based inspection...
Quality & Compliance
Gene therapy holds the promise of curing severe genetic diseases at the genetic level rather than merely treating the symptoms as is accomplished using conventional small-molecule drug therapies. In...
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...
Regulatory Sciences
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
Regulatory Sciences
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...
Quality & Compliance
If your only method of quality assurance is software testing, you're wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
Quality & Compliance
Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders (MAH) to ensure supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of...
Quality & Compliance
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...
Regulatory Sciences
On March 11, 2020, after months of researching, strategizing, and meeting with various leaders and medical experts globally, the World Health Organization (WHO) declared COVID-19 to be a global...
Quality & Compliance
Many of us have been faced with this beast that needs taming: a regulatory agency has conducted an inspection of your facility. Their observation is that the backlog of investigations at your site is...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...