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.
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...
Investments in digital transformations are expected to grow from $594.5 billion USD in 2022 to $1.548.9 billion USD by 2027, with the goal of improving the generation, collation, storage, and...
Clinical Research Solutions
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...
The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...
Quality & Compliance
This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...
Quality & Compliance
This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...
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
Recently, there have been two notable cases regarding pharmaceutical advertising code violations based on LinkedIn content. It was announced that Danish drugmaker Novo Nordisk has been suspended by...
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
Regulatory Sciences
Product development is an extremely time consuming and challenging process for any pharmaceutical, biotechnology, or medical device, but when it comes to cell and gene therapy products, the process...
Quality & Compliance
This article has been updated since its original publication date. ProPharma holds its own MIA licenses both in the Netherlands to cover batch importation and Qualified Person (QP) batch...
ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades. Lord O’Shaughnessy Clinical Trial...
Quality & Compliance
MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of effectiveness the Modernization of Cosmetics Regulation Act of 2022 or "MoCRA" was...
How do we improve outcomes for an uncommon healthcare challenge in a community challenged with common healthcare issues? The Orphan Drug Act defines a rare disease as a disease or condition that...
After panning over the Boston Business Journal and seeing yet another local VC (Venture Capital) firm raise a record $350 million in venture capital for Massachusetts life science, I asked myself:...
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...
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...
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...