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.
Clinical Research Solutions
Implementing a multidisciplinary approach in cell and gene therapy product development is critical to the product’s eventual success or failure. In our experience, the consequence of not effectively...
Clinical Research Solutions
How much is too little versus too much when developing quality systems and controls for investigational cell and gene therapies? Because these therapies are being administered to patients during all...
Clinical Research Solutions
Yes, there is a light at the end of the long, dark COVID-19 tunnel, and people’s lives will return to a state of normalcy. However, what will the new state of normalcy look like in a post COVID-19...
Clinical Research Solutions
Research and development is a key component in the successful discovery and development of new drugs and medical devices entering the market. It’s also an area of big business, with investments in...
Clinical Research Solutions
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...
Clinical Research Solutions
Much like buying a home as an individual, a company contemplating the acquisition of a new product or business requires a lot of research and fact checking. In both situations, it is critical for the...
Regulatory Sciences
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
Clinical Research Solutions
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Clinical Research Solutions
Now that we have wrapped up the year 2020, it’s important to look ahead and prepare for upcoming regulatory deadlines. It is essential to address these changes and develop a plan, albeit nimble as...
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...