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
The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...
Clinical Research Solutions
In a Federal Register notice to be published on Dec. 10, 2013, FDA announced the release of a new guidance titled “Size, Shape and Other Physical Attributes of Generic Tablets and Capsules.” The...
Quality & Compliance
Today I would like to present the third entry in the series discussing the Nine Gate Transfer Process for moving production from site to site: the Gate 3 Transfer Plan. In case you missed them, you...
Clinical Research Solutions
A wise man recently told me that “honor and respect should be given freely, but trust is earned”. Whether it’s in politics, friendships, church, marriages, parenting or even the business world,...
Quality & Compliance
In this, the second entry in the series, I will review Gate 2 of the Nine Gate Transfer Process utilized by ProPharma Group for successful technical transfers. Refer to my first entry for further...
Clinical Research Solutions
On Nov. 13, 2013, the Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register. The title of the Proposed Rule is “Supplemental Applications Proposing Labeling Changes for...
Clinical Research Solutions
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
Quality & Compliance
Pharmaceutical news today featured another article about a manufacturing plant closure and the layoff of a thousand employees. Demand for pharmaceutical products continues to grow and will continue...
Clinical Research Solutions
Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA...
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...
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...
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...
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...
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...