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.
Today’s patients benefit from having access to the safest, most advanced pharmaceutical systems around the world. This is because of the work done by the various regulatory bodies who govern the...
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
At the start of every year, we all have these grand plans of everything we plan to accomplish. It is a fresh start to really get stuff done and we have a full 12 months to do it all. However,...
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...
Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
We live in a world of data: there’s more of it than ever before, in a ceaselessly expanding array of forms and locations. Besides this, most people in their organizations are not always aware of data...
A Project Management Office ("PMO") can be incredibly advantageous to large companies with many ongoing projects across various job sites. A PMO streamlines project management processes to make a...
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
It's no secret. To be successful in the life sciences industry you must accomplish a lot – achieve and maintain profitable growth, deliver safe and effective products to patients quickly, manage...
The Medical Device Single Audit Program (MDSAP), initiated by the International Medical Device Regulators Forum (IMDRF), created a global approach to auditing and monitoring the manufacturing of...
Over recent years relations with data and its weight have changed significantly; consequently, an assessment of Company Data Integrity is becoming one of the key metrics of corporate functionality...
When it comes to usability studies, the focus should be on effectively preparing the medical device for use in humans. Whether a Sponsor is conducting formative testing or validation testing, the...
Quality & Compliance
Every industry has a distinct set of obstacles to overcome, but it’s no secret that the life sciences industry encounters more speedbumps than most. Market cycles and product failures are expected,...
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 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...
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...