Insights On Regulatory Compliance
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Don't Skip Preformulation: Your Blueprint For Drug Development Success
9/22/2023
Investing in the right preformulation studies and gathering evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight.
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How Crucial Is Culture Media Selection In Environmental Monitoring?
6/20/2023
Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.
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Navigating The Future Of Lab Developed Tests
3/14/2025
Explore the pivotal role of lab-developed tests (LDTs) in medical diagnostics, their growing regulatory scrutiny, and their future trajectory in modern healthcare to advance patient care.
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Guide To PUPSIT And Annex 1 In Aseptic Processing
12/5/2024
Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.
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Efficient Pathways: The Regulatory Edge Of New Zealand For Pharmaceutical Development
7/29/2024
By leveraging the country's regulatory advantages and partnering with a New Zealand-based CDMO, international companies can accelerate approvals and navigate the regulatory pathway with ease.
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Characterizing The Effects Of Moisture On Pharmaceutical Materials
12/30/2024
Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discovery SA enables humidity and temperature profiling for improved drug formulation.
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Unlocking The Potential Of Digital Transformation Tools In The Biopharmaceutical Industry
10/4/2024
Why do many BioPharma organizations still struggle to gain the crucial benefits they desire from their data and digital transformation tools?
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Navigating The Paradigm Shift: Ensuring Efficacy In Risk-Based Cleaning Validation
10/23/2024
Unearth how adopting a risk-based approach to cleaning validation can enhance product quality, safety, and regulatory compliance in pharmaceutical manufacturing.
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Maximizing ROI: Extracting Value From Analysis And Reporting
7/3/2024
How can organizations establish the foundation for advanced analytics, AI and ML, in pursuit of a robust and adaptive lab of the future?
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Five Steps To Implementing CSA
12/17/2024
Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.