ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
A Quality Management System (QMS) bridges an organization’s individual compliance practices with regulatory requirements. It establishes the infrastructure and oversight requirements for...
Quality & Compliance
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...
R&D Technology
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
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...
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...
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...
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...
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...
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...