Insights On Regulatory Compliance

  1. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

    Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

  2. Digital Solutions For Accelerated Innovation 5/19/2025

    In this webinar, hear how Applied Biosystems AccuSEQ software serves as an advanced digital tool that can help streamline bioanalytical processes and accelerate the delivery of life-changing therapies.

  3. Data Governance And AI In Pharma: Overcoming Challenges In DACH Region 4/11/2025

    Gain insights from industry experts on the implications of the EU's AI Act for data governance professionals, ensuring your organization remains compliant while leveraging AI's transformative potential.

  4. The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets 3/28/2024

    Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.

  5. Ensure Consistency Across Batches With A Powerful Tool 5/19/2025

    Learn how to streamline bioprocess control with an innovative software's Unit Save and Load feature. Save configurations, reduce setup time, and ensure consistency across batches with this powerful tool.

  6. 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.

  7. Rising Sun: The Drug Pricing Environment In Japan Is On The Up 3/18/2025

    Japan’s recent pharmaceutical pricing reforms present new opportunities for the industry, fostering innovation while aiming to ensure faster access to treatments.

  8. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  9. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

  10. Navigating Your Holistic Approach To CCI For Biologic Drug Products 6/12/2024

    Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.