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The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
Clinical Research Solutions
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...
In the latest PMI report Pulse of the Profession 2020 (2020), 11.4% of surveyed organizations attribute investment waste to poor project performance. What defines project performance and ultimately...
Quality & Compliance
What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...
Regulatory Sciences
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...
In the first blog of this three-part series, “Overlooking Your QMS Could Cost You,” we discussed the cost of “good” versus “poor” quality, and the importance of investing in a “good” Quality...
Drug and medical device development and manufacturing is a complex process that involves multiple supply chains, various monitoring systems, and countless players from R&D to market. Due to the...
Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...
Quality & Compliance
A Quality Management System (QMS) bridges an organization's individual compliance practices with regulatory requirements. It establishes the infrastructure and oversight requirements for...
Clinical Research Solutions
The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...
Digital Transformation
In 2017, R&D investments in the pharmaceutical space reached more than $70 billion, with projected figures of over $200 billion by 2024. Pharma is one of the two sectors with semiconductors that are...
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to...
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...
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...
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...
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...