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
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
12 Critical Questions and Answers for a Successful Tech Transfer
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Three Things 2021 Has in Store for Pharmaceuticals
Now that we have wrapped up the year 2020, it’s important to look ahead and prepare for upcoming regulatory deadlines. It is essential to address these changes and develop a plan, albeit nimble as...
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...
Top 9 Failure Points During Nonclinical Development
The process of drug development involves clinical and nonclinical studies. Nonclinical studies are considered crucial for understanding the safety of new drugs. Before testing a drug in people,...
As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...
Stability Testing of New Drug Substances and Products
The stability of a drug substance or product is a critical attribute for all pharmaceutical products. As such, stability testing is required throughout the drug development phase as well as...
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit...
The Truth Can Hurt - But Hearing It at the Right Time Can Save Time and Money
No one has an ugly baby. At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. But the unfortunate fact is that there are ugly babies....
