Insights On Regulatory Compliance
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Practical Applications Of ICH E6(R3): What Do We Need To DO?
12/14/2023
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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Analyzing COVID-19 Vaccine Purity Using LC-MS Technologies
11/8/2022
Explore why process-related impurities are a concern in vaccines and present results and learnings from LC-MS analyses of several mRNA- and protein-based vaccines for COVID-19.
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Critical Considerations For Buffer Preparation
8/7/2023
Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.
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Tips For Viral Vector Production
4/16/2024
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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Intro To USP <1062> - What It Is And Why You Should Use It
7/20/2023
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.
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Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance
10/18/2023
Ensuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.
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EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
4/12/2024
As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.
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The Future Of The FDA: Operating In An “Electronic World”
7/6/2022
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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The Container Closure Integrity Requirements In The Revised EU Annex 1
11/21/2022
Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.
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Why You Need A Document Management System In Life Sciences
8/25/2022
In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.