Regulatory Insights

  1. Evolution Of Clinical Trials In Europe 3/17/2025

    The CTR and CTIS represent a paradigm shift in European clinical research, fostering a more efficient and transparent trial environment.

  2. The Future Of Good Clinical Practice: The ICH E6(R3) Update 3/17/2025

    The release of the ICH E6(R3) Good Clinical Practice guideline in January 2025 marks a shift in clinical research, with significant implications for CROs, trial design, and quality management. 

  3. Three Key Takeaways From The PDA Annex 1 Workshop 3/17/2025

    Annex 1's impact on sterile manufacturing was dissected at PDA's Dublin workshop. Regulators stressed risk management, centralized control strategies, and the value of personnel knowledge.

  4. Collaboration, Local Knowledge Key To The Nordic Pharmaceutical Market 3/17/2025

    Companies looking to tap into the Nordic pharmaceutical market must recognize the unique blend of shared values and individual regulatory landscapes that define its unique approach to healthcare.

  5. Preparing Documents For Transparency And Disclosure Requirements 3/14/2025

    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.

  6. Data Quality Framework For EU Medicines Regulation 3/14/2025

    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.

  7. ICH Q10 Guideline Checklist 3/14/2025

    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.

  8. 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, ensure continuous improvement, and uphold regulatory compliance.

  9. 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.

  10. 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.