FEATURED ARTICLES

• Preparing Documents For Transparency And Disclosure Requirements

  Learn how transparency and disclosure ensure that clinical data is accessible to the public and regulatory bodies in medical writing, which helps foster trust and accountability in the scientific community.

• Data Quality Framework For EU Medicines Regulation

  Ensure compliance with the EU Data Quality Framework for medicines regulation by using this checklist or consulting with experts for personalized guidance to refine your data quality strategies.

• ICH Q10 Guideline Checklist

  Discover an ICH Q10 checklist that provides a global framework for pharmaceutical quality systems to ensure consistent standards from development to commercialization and enhances patient safety.

• Guide To Pharmaceutical CAPA And Quality Management

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

• GMP Compliance For Pharmaceuticals And Medical Devices

  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.

• Best Practices For Internal Quality Audits In Life Sciences

  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.

• Unpacking FDA's Final Rule To Regulate LDTs

  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.

• Navigating The FDA's Drug Supply Chain Security Act

  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.

• Navigating The Future Of Lab Developed Tests

  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.

• A Guide For Quality Professionals In Healthcare And Life Sciences

  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.