Insights On Regulatory Compliance
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Leachables Method Development, Validation And Relevant ICH References
5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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What Is The Position Of Regulatory Authorities On PUPSIT?
5/2/2025
PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.
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How Compliance-Driven CDMOs Win Sponsor Contracts
8/6/2025
Discover how evolving global regulations are reshaping CDMO strategy. and how digital infrastructure helps manufacturers stay audit-ready, build sponsor trust, and turn compliance into an advantage.
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Winning Strategies For Oral Dosage Form Development And Manufacturing
10/7/2024
Failure to identify a compound’s red flags early in development often manifests as program delays or failures. Discover how to avoid these setbacks through complete molecular characterization.
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A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems
10/3/2024
One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.
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Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation
11/6/2024
Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China
11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing
8/20/2024
Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing
5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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Reducing Risk, Decreasing Timelines, And Optimizing Outcomes
8/7/2025
Explore the challenges of cell line development (CLD) in biologics commercialization and discover how integrated solutions can streamline your strategy, reduce risks, and optimize outcomes.