Insights On Regulatory Compliance

  1. Increasing Efficiency Of Production With Intelligent MBR Design 2/24/2025

    Discover how to enhance your pharmaceutical production efficiency with an intelligent MBR design that offers tailored software, handling systems, and inspection machines.

  2. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  3. Cleanroom Classification Zone Creation For ISO 14644, Annex 1, China GMP 6/11/2024

    Discover a particle counter that automatically determines the number of sample locations needed based on the sampling size of the area, enabling the easy selection of classification for certification.

  4. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  5. Optimizing Cleanroom Cleaning And Disinfection To Meet Annex 1 Requirements 12/27/2024

    Explore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.

  6. Tapping Into The Unexplored Through 505(b)(2) Pathway 10/9/2023

    Leveraging the the 505(b)(2) regulatory pathway can enable an accelerated approval timeline and help advance your drug product to market. Review the three statutes that govern the approval pathways.

  7. FDA Recall Prevention: Save Time, Money, And Reputation 10/8/2024

    FDA product recalls pose significant challenges for life sciences companies. Avoid recalls with these actionable steps to mitigate risk, ensure compliance, and safeguard your organization's reputation.

  8. 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.

  9. EMA Adopts Collaborative Approach With ATMP Guideline Update 7/17/2024

    The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.

  10. Three Key Strategies To Guide Efficient And Effective Recall Management 2/18/2025

    Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.