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 January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor...
Regulatory Sciences
How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking...
Regulatory Sciences
Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health...
Quality & Compliance
In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. One crucial aspect of this assurance lies in the oversight provided by...
Regulatory Sciences
To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By...
Regulatory Sciences
The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...
R&D Technology
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 April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...
Medical Information
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
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...
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...
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
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...