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Clinical Research Solutions
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...
Clinical Research Solutions
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...
Clinical Research Solutions
Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...
Clinical Research Solutions
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
Clinical Research Solutions
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...
Clinical Research Solutions
At the recent Pharmaceutical Compliance Congress (PCC), Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania stated that one of the key questions that a company should ask about its...
Clinical Research Solutions
For most drugs, the process of developing and obtaining FDA approval of a generic version is simple and well-defined: sponsors must only prove that their product is pharmaceutically equivalent and...
Quality & Compliance
Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...
Clinical Research Solutions
When the OTC drug review was undertaken in the 1970s, it was deemed the best solution available at the time for efficiently assessing the safety and efficacy of the countless drug products being sold...
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
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...
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...
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...