Insights On Regulatory Compliance

31. High-Resolution Characterization Of Both sgRNA And Cas9 mRNA 8/8/2023

    Improve your characterization of both RNA integrity in the final product and RNA fragmentation with an analytical kit-based solution.

32. Lifecycle Planning For Containment And Delivery Of Biologics Drug Products 6/20/2024

    Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.

33. Industry Insights In Isolator Technologies And Aseptic Processing In Pharma 8/30/2024

    Explore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.

34. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

    As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

35. Lessons Learned From Implementing FDA CSA Guidance 2/20/2024

    Explore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.

36. The Importance Of 503B Facilities In Drug Manufacturing Today 10/5/2023

    Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.

37. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

38. Resource Savings Through Effective Global Trade Compliance 5/16/2024

    Ensure consistent planning, accurate cost estimation, and enhanced delivery timelines for materials shipped across borders by partnering with a CDMO equipped with a dedicated trade compliance team.

39. Jumpstart Your QMSR Transition: Get Ahead Of Evolving Regulations 5/16/2024

    Join industry experts as they guide you through your transition to the QMSR, discussing key changes and the impact of new requirements, and ensuring that your company achieves compliance.

40. 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.