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.
Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
2020 in Review: Reflecting on the Biggest Events & Breakthroughs
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
Is Your Technical Transfer Process Aligned with Process Validation Requirements?
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
4 Common Bottlenecks to Avoid in the Development of Biopharmaceuticals
If you are involved in early development of biopharmaceuticals, have you ever experienced serious delays because of problems arising from tech transfer, from the first pilot scale batches not meeting...
As we begin to wrap up the year and look ahead to 2021, it is critical to prepare your team for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring...
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...
Improve Quality Using an Organizational Maturity Model
If this is your first introduction to an Organizational Maturity Model (OMM), you may have a few questions. What is an OMM? What are some common obstacles I might face when implementing an OMM? How...
Understanding EMA and FDA Regulations on Nitrosamine Control
On September 26, 2019, the European Medicines Agency (EMA) released an advice to Marketing Authorization Holders (MAH) of human medicines to review their drug products on possible presence of...
The Role of Clinical Data and Clinical Data Science
Clinical data and its analysis are critical to clinical research. Ensuring the overall quality of clinical data is then paramount to ensuring quality care and appropriate decision-making in the...
