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Regulatory Sciences
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
A common principle in Operational Qualification (OQ) studies is to challenge processes under worst case conditions. A "worst case" condition or set of conditions are generally those parameters...
Quality & Compliance
Believe it or not, project bullying in the workplace does exist. It is not a threat only at schools and on playgrounds. Project bullying can come for any source including the Project Manager, the...
Clinical Research Solutions
So what’s all the hub-bub about Digital Health? Is it really as big as they say? Is it just a fad? Is it all hype? Well, my answer is yes to all of the above. As with all major new technologies and...
Clinical Research Solutions
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
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Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...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...
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...