Insights On Regulatory Compliance

  1. How To Get Ready For 21 CFR Part 820/ISO 13485 Harmonization 9/20/2024

    Explore the key aspects of the harmonization between 21 CFR Part 820 and ISO13485 and guidance regarding how to ensure compliance with the new Quality Management System Regulation (QMSR) standards.

  2. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

    Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

  3. EU To U.S. Market: Understanding 3 Core Regulatory Contrasts 9/20/2024

    Learn about three key regulatory differences between the United States and the European Union that can significantly impact the success of your market entry.

  4. FAQs On The Revised EU GMP Annex 1: Volume 2 3/5/2025

    Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

  5. Top 3 Life Sciences Compliance Strategies Every Startup Needs 1/28/2025

    Life sciences startups must integrate compliance early to ensure regulatory approval, and trust. Prioritizing compliance streamlines processes, and enables long-term success in this highly regulated industry.

  6. Key Takeaways From The ISPE Ireland Annex 1 Event 4/12/2024

    Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.

  7. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

  8. Client Story: Efficiency Enabling CSV At Scale 7/1/2025

    Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

  9. Q&A Interview: Navigating The Launch Of ATMPs In Europe 5/29/2024

    Dive into this overview of the evolving regulatory landscape and better understand the importance of proactive planning, collaboration, and expert guidance in navigating the ATMPs ecosystem in Europe.

  10. A Blueprint For Avoiding FDA Recalls 10/9/2024

    Avoid FDA recalls and safeguard your life sciences business. Learn how QMS and EBR/eDHR solutions can prevent costly product recalls and ensure compliance with FDA regulations.