I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I'll share my insights and key takeaways from the...
Premier Research
Adherence to cGMP regulations assures the identity, potency, purity and quality of biologics or advanced therapeutics and helps ensure adequate control of manufacturing operations. A primary way to demonstrate these attributes for a biologic product under development is through assays....
We spoke with some Clinical Leads to answer the question: “Why Premier Research?” Here’s what we heard. A Focus on Career Growth Premier Research often promotes from within. “Keep growing” is one of our Core Behaviors, so management proactively supports...
Premier Research exists for one reason: To transform life-changing ideas and breakthrough science into new medical treatments. We care about improving human health and that starts with the health and wellbeing of our own team members, not only by offering...
You found an exciting role at Premier Research and have scheduled an interview. Amazing! Now you need to make a good first impression. It’s natural to be a little nervous, but you are up to the challenge. These 9 tips...
The FDA's January 2020 guidance, Chemistry, Manufacturing and Control (CMC)[1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics. The analytical package, consisting of...
Medical Device
5 Stages of Medical Device Development
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to...
Rare Disease
Why Rare Disease Day Matters to Us
An estimated 300 million people globally suffer from a rare disease. Further still, 25 million people in the U.S. alone are living with an undiagnosed rare disease. Limitations in disease understanding and lack of approved treatments can mean countless challenges...
“You have cancer.” It’s something you hope to never hear. For so many of us at Premier Research, we’ve watched loved ones fight for their lives — or fought for our own. That’s why we choose to work at Premier,...
In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval....