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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)...
Quality & Compliance
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...
Clinical Research Solutions
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...
Regulatory Sciences
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...
Quality & Compliance
Is remote Computerized Systems Validation the future standard? Crises are fertile ground for inspiration and creativity resulting in practical new ideas for the near future, as is the case during the...
Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...
Everything You Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from...
Clinical Research Solutions
In order to optimize the storage and reuse of data within your organization, we recommend that you consider implementing data standards throughout your business. In our previous blog post "An...
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....
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...
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 was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...
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...