Insights On Regulatory Compliance

  1. How Intuitive Decision Rules In Clinical Trials Can Support Regulatory Requirements 6/12/2024

    See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.

  2. Managing Nitrite Impurities: Supplier-Manufacturer View 12/19/2024

    Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.

  3. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

  4. 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?

  5. Key Considerations When Developing Your Combination Product 2/20/2024

    Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

  6. Nitrosamine Impurities Deadline: Are Your Products Compliant? 11/6/2023

    The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.

  7. Electronic Batch Reporting 1/22/2024

    Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

  8. 5 Drug Manufacturing Trends To Look For In 2025 1/6/2025

    The life sciences industry faces big changes in 2025. Companies must adapt to new regulations, AI, and shifting manufacturing landscapes to stay competitive and drive innovation.

  9. 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.

  10. Achieving The Three Pillars In Life Science Manufacturing Validation 12/27/2024

    IQ, OQ, and PQ validations ensure equipment reliability, compliance, and quality in medical device and pharmaceutical manufacturing, meeting regulatory standards.