White Papers

  1. Best Practices For Internal Quality Audits In Life Sciences 3/14/2025

    Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

  2. Unpacking FDA's Final Rule To Regulate LDTs 3/14/2025

    Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.

  3. Navigating The FDA's Drug Supply Chain Security Act 3/14/2025

    Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

  4. 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.

  5. A Guide For Quality Professionals In Healthcare And Life Sciences 3/14/2025

    Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.

  6. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  7. Modern Modeling Tools For Small Molecule Solid Dose Manufacturing 3/10/2025

    Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

  8. Molecular Properties Of PROTACs And The Relationship To Formulation Design 3/4/2025

    Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.

  9. Improving API Solubility 3/3/2025

    Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

  10. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.