Two famous pharmaceutical industry quotes encapsulate industry thinking and the push for progress in recent years. Upon...
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Resources
Live from the PDA Annual Meeting: Risk Management in Combination Products and Co-Packaged Kits
From post-aging performance testing to container closure integrity, robust design controls extend far beyond “constituent part” requirements. With the increase in complexity...
Therapeutic Gene Editing: An American Society of Gene & Cell Therapy White Paper
Interested in learning more about gene editing and its therapeutic applications? Download a new white paper from the American Society of Gene & Cell Therapy (ASGCT). The...
4 Steps for Managing Biopharmaceutical Projects
Note: BioTechLogic is proud to be featured in the December 2016 issue of Pharmaceutical Manufacturing magazine. The global biopharmaceutical market is expected to grow at a...
White Paper: 4 Steps for Managing Biopharmaceutical Projects
white paper 4 Steps for Managing Biopharmaceutical Projects By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, and Julie Spyrison Associate Director,...
The Formation of the Combination Products Policy Council to Improve Regulatory Efficiency
Combination drug products (i.e., products that are a combination of a medical device and/or a drug and/or a biologic) are inherently complex to manage, particularly due to...
