Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow...
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Articles
The EU Clinical Trials Regulation – Experiences from the First 18 Months
Originally posted on Regulatory Focus – a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial...
CMC Expertise Accelerating Biologics Development for 20 Years and Counting
Tracy TreDenick-Fricke Founding Partner, Head of Regulatory and Quality Working with my co-founders, colleagues, and clients on many fascinating projects over the last...
AAV Viral Vector Production at Scale—Improving the Current State
The gene therapy sector is continuing to come into its own, and many developers are shifting their attention from nearly exclusively treating rare diseases to developing...
A Guide to Integrating QbD in Gene Therapy CMC Programs
Cell and gene therapies have a potential, unlike anything we’ve ever seen before in medicine. With the power to deliver curative relief to patients suffering from...
Combination Drug Products– Regulatory Landscape Update
In 2016 we released a paper, “4 Things You Need to Know About Combination Drug Compliance.” This paper is still entirely relevant today, and we encourage you to download it,...
