White Papers

  1. Pioneering Gene Therapy In Rare Diseases 3/17/2025

    Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models.

  2. Guide To Pharmaceutical CAPA And Quality Management 3/14/2025

    CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.

  3. GMP Compliance For Pharmaceuticals And Medical Devices 3/14/2025

    Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. A Guide To Digital Endpoints In Major Depressive Disorder 3/7/2025

    The integration of digital health technologies (DHTs) in clinical trials for Major Depressive Disorder (MDD) is transforming how symptom severity and treatment efficacy are measured.

  10. The Evolution Of Technology For Safety Notifications 3/6/2025

    Discover how a digital-first approach empowers sponsors to optimize safety management and drive operational efficiency in an increasingly complex, global clinical landscape.