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The Regulatory Guidance embodied by ICHQ8 through (soon to be written) ICHQ12 tells us in no uncertain terms that we must protect the patient across the product lifecycle by assuring quality based on...
Quality & Compliance
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...
In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
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...
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...
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...
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...
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...
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...
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...
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...
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...
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...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...