Meet the Expert: Carrie Rabe
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...
Meet the Expert: Gary Hyde
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...
Clinical Research Solutions
The Anniversary We Didn’t Want: One Year of COVID-19 Milestones
On March 11, 2020, after months of researching, strategizing, and meeting with various leaders and medical experts globally, the World Health Organization (WHO) declared COVID-19 to be a global...
Understanding FDA Pre-ANDA Meetings
Brought into being by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), the FDA’s pre-ANDA program is designed to accelerate access to generic versions of complex products. The...
Biomanufacturing World Summit
The Biomanufacturing World Summit brings together the “who’s who” of pharmaceutical executives and cutting-edge technology providers for North America’s premier biologics event. Make plans to attend,...
How to Manage the Risk of Elemental Impurities with ICH Q3D
How to Manage the Risk of Elemental Impurities with ICH Q3D: The mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to ensure...
What It Takes to Be Successful with GDUFA in 2021
GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022. The continuing goal of the amendment is to facilitate timely access to high-quality,...
7 Tips to Help You Prepare for Compliance in a Post COVID-19 World
Yes, there is a light at the end of the long, dark COVID-19 tunnel, and people’s lives will return to a state of normalcy. However, what will the new state of normalcy look like in a post COVID-19...
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,...
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...
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....
Meet the Expert: Robert Beall, PMP
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...
Meet the Expert: Daniel Wong
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...
5 Tips for Achieving Regulatory Success in 2021
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...
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...