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On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
Regulatory Sciences
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
Clinical Research Solutions
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
FDA is investigating the use of tramadol, a narcotic-like pain reliever, in children aged 17 years and younger after learning of the “rare but serious” risk of slowed or difficult breathing....
Generating process data is expensive: Costs include materials, process time and the focus of highly-compensated subject matter experts. Unfortunately, many organizations don’t get their money’s worth...
Quality & Compliance
In the previous installment of this blog, we discussed the importance of establishing a Master Validation Plan, and how to plan and assess your validation approach. Today’s segment will complete the...
Do you find yourself in one of the following situations? + Your equipment has broken down due to frequent usage or wear and thus requires repair. You realize that once repaired, any equipment will...
computer susteIt’s a Friday afternoon. Quarter’s end. Your V.P. of Regulatory Affairs calls your office bellowing something about not being able to process the latest submission data- can’t access...
Business sustainability is an often heard buzz phrase, but how does it apply when a costly process validation is imminent? Process validation is not only a regulatory compliance issue; it is also a...
Quality & Compliance
Since the day I entered the industry the mantra of "If you didn’t write it down, it didn’t happen" was repeatedly drilled into my daily mode of operation. The margins of my test sheets were filled...
Quality & Compliance
Today, ProPharma's Simona Gherman adds to her series on Media Programs and media fills. Part I of this series was an overview with background information and tips. Part II focuses on what you need,...
Regulatory Sciences
On May 5, 2015, the Food and Drug Administration (FDA) released the final guidance on Providing Regulatory Submissions in electronic format. The guidance implements the electronic submission...
Quality & Compliance
>Would your media program pass the test? The FDA inspection test, that is. In this new blog series, ProPharma Group’s Simona Gherman breaks down the FDA regulatory requirements for a successful media...
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...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
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...
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...
The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...