Insights On Regulatory Compliance
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When Should Filter Validation Be Performed?
8/21/2024
Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.
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How Robotic Isolator Technology Aligns To Annex 1 Principles
4/28/2025
Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.
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A Complete Guide To Capsule Checkweighing
5/2/2025
Understand why accurate capsule weighing is essential for therapeutic efficacy, safety, and adherence to pharmaceutical manufacturing standards.
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Key Regulatory Considerations For The Next Wave Of Gene Therapies
2/21/2025
The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.
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Over The Hurdles: Taking Psychedelics From Schedule I To Pharmacy
10/12/2023
Learn how a partner with experience in handling scheduled substances and navigating FDA and DEA regulation can help you advance toward clinical research and drug development with ease.
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A New Approach To Isolator Decontamination
4/8/2024
How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.
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Managing Nitrite Impurities: Supplier-Manufacturer View
12/19/2024
Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.
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How A Rigorous Approach Delivers Unparalleled Results
6/12/2025
In critical environments where mistakes have serious consequences, a disciplined, methodical approach isn't just a preference—it's the only path to success and long-term operational excellence.
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CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics
4/28/2025
CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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Move Beyond Manual CQV Challenges With Digital Solutions
1/24/2025
Review how digitalizing commissioning, qualification, and validation (CQV) with a new software streamlines processes, enhances compliance, and reduces time to drive efficiency and sustainability.