Originally posted on Regulatory Focus – a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul...
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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,...
New European Medical Device Regulations Delayed Due to COVID-19 Pandemic
Tonia Becker, Life Sciences Editor, Macon Raine talks with BioTechLogic’s Ted Condez How is the medical device and biopharmaceutical market faring during the COVID-19...
Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes
WHITE PAPER Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes The European therapeutics market has been working to manage the upheaval...
Cell Therapies – Overcoming Challenges Within the Regulatory Framework
WHITE PAPER Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework Within the cell therapy arena, regulators, the medical community and industry...
FDA Seeking to Enhance Manufacturing of Cell Therapy and Gene Therapy Products
More consistent and reliable production cell therapy and gene therapy processes are critical for advancing innovative treatments. While cell therapy and gene therapy...
