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.
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...
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...
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...
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...
Brought into being by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), the FDA’s pre-ANDA program is designed to accelerate access to generic versions of complex products. The...
Quality & Compliance
After assuring clinical validity, finding and managing the right contract manufacturing organizations (CMOs)/contract development manufacturing organizations (CDMOs) is a Sponsor's major concern when...
The Biomanufacturing World Summit brings together the “who’s who” of pharmaceutical executives and cutting-edge technology providers for North America’s premier biologics event. Make plans to attend,...
A combination product is composed of any combination of a drug and a device; a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. Consider...
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...
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...
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...
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...
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...