Insights On Regulatory Compliance

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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?

  8. 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.

  9. 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?

  10. 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.