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
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...
Clinical Research Solutions
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...
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
ProPharma’s Research Consulting Organization (RCO) model offers a fully customizable alternative for partnership with clients and sponsors. This year’s theme for World Health Day Health For All...
Clinical Research Solutions
This article has been updated since its original publication date. Product development is an extremely time consuming and challenging process for any pharmaceutical, biotechnology, or medical device,...
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Medical Information
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...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Regulatory Sciences
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...
Regulatory Sciences
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...