By Ashley Ruth, Senior Consultant, Analytical Services, BioTechLogic The pharmaceutical and biopharmaceutical industries must give immediate...
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Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework
By Tracy TreDenick, Head of Regulatory and Quality Assurance, BioTechLogic While the field of stem cell therapy has been in development for decades, most notably with the...
Comprehensive Regenerative Medicine Policy Framework Announced by FDA
On November 16, 2017 the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products,...
The FDA’s Groundbreaking Strides Toward a Quality-Centric Regulatory System
Two famous pharmaceutical industry quotes encapsulate industry thinking and the push for progress in recent years. Upon launching Pharmaceutical cGMPs for the 21st Century –...
Why Pharmaceutical Data Integrity Is More Important Than Ever
With radical pharmaceutical industry changes in the air, the importance of data integrity and the steps the pharmaceutical industry must take are clear. By Ashley Ruth,...
Response to the Publication of USP ‹1207›: Package Integrity Evaluation-Sterile Products
The BioPhorum Operation Group’s (BPOG’s) Container Closure Integrity Testing (CCIT) workstream would like to congratulate the United States Pharmacopeia’s committee for its...