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Clinical Research Solutions
As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process...
Clinical Research Solutions
On Tuesday, June 14, the “Creating and Restoring Equal Access to Equivalent Samples Act of 2016” (CREATES Act) was introduced by members of the Senate Judiciary Committee. This bipartisan bill...
Clinical Research Solutions
The core of my background was built upon analytical development science for biotechnology companies including Celera and Genentech. It became routine to develop analytical assays to test products...
Clinical Research Solutions
Those of you in the pharmaceutical, biotech and medical device industries who encounter process and product problems on a regular basis, you likely grimace when one lands in your lap. There is a...
Clinical Research Solutions
On June 13, FDA released a new pharmacology/toxicology guidance providing guidance on nonclinical studies to support the approval of drugs intended for the treatment of osteoporosis. This guidance...
Clinical Research Solutions
On Thursday, June 2nd FDA released the final Individual Patient Expanded Access Investigational New Drug Application (Form FDA 3926), which is a new form for physicians to use when requesting...
Clinical Research Solutions
On Monday, June 6th the FDA issued a Drug Safety Communication, warning consumers about the increased risk of serious bleeding associated with the use of over-the-counter (OTC) antacid products that...
Clinical Research Solutions
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Clinical Research Solutions
On August 28, 2015, FDA announced the availability of a draft guidance, entitled “Nonproprietary Naming of Biological Products,” which established a naming convention for biological products. The...
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...