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 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...
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...
Regulatory Sciences
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...
Since September 26, 2019, all EU Marketing Authorization Holders (MAHs) of medicines for human use are facing what might be regarded as a new requirement: review their drug products on the possible...
Clinical Research Solutions
Medical writers need to meet a few critical criteria before they publish their work. First and foremost, people want to see accuracy and explicit knowledge of the field when they’re seeking out...
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...
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....
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 is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
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...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...