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.
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...
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
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...
On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result...
The FDA's Breakthrough Devices Program is intended to expedite the development of innovative technologies for patients with life-threatening or irreversibly debilitating diseases or conditions. 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...
Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...
Expert Consultant, Regulatory Sciences 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...
Regulatory Sciences
Are you truly up to speed on the most effective strategies to expedite the approval process for your innovative product in Europe's evolving regulatory landscape? In the United States (US), the Food...
A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...
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...
In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices, and other regulatory requirements is paramount. Failure to meet these...
The FDA has recently published a number of software related guidance documents, covering topics such as off-the-shelf software, cybersecurity, closed-loop-control, and predetermined change control...
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...
Setting the Scene: What Makes Oncology Clinical Trials Different? Ever increasing knowledge of the molecular basis of malignant disease has stimulated development of targeted agents. This often leads...
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...