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
So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech...
Clinical Research Solutions
In the highly regulated medical device industry, navigating FDA's submission process can be daunting, especially for start-ups. However, FDA's Q-Submission (Q-Sub) program offers a valuable...
Medical Information
The journey from compound discovery to market-ready pharmaceutical product is long, complex, and resource-intensive. Only about 1 in 5,000 drug candidates make it to patients1, underscoring the need...
Quality & Compliance
So, you're thinking about Technology Transfers (i.e., TT, Tech Transfer)? Who can blame you? There has been a significant amount of news recently regarding tariffs and the potential for bringing...
Quality & Compliance
Remember the last time you were pulled over by law enforcement? Maybe it was for a broken taillight or driving a few miles over the speed limit. Even if you believed you hadn't done anything wrong,...
Clinical Research Solutions
For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the...
Medical Information
Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...
Medical Information
The COVID-19 pandemic challenged nearly every aspect of healthcare delivery—and medical information (MI) services were no exception. As patients and healthcare professionals (HCPs) urgently sought...
Quality & Compliance
Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...
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...
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...
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...
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...
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...
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...