• Avoiding Potential Pitfalls: Phase Appropriate CMC Development And Regulatory Considerations

    In this webinar, development and regulatory experts will discuss the phases of oral solid dosage form development from a CMC perspective. At each phase, they will identify the minimal expectations for CMC development and filing, as well as other considerations to address, thereby setting the stage for later success. In addition, they will present key learnings and past experiences of issues that came up, how they were resolved, and how they could have been avoided or mitigated by taking certain strategic actions earlier in development.

  • Webcast: A Guide To USP <922> For Water Activity Determination

    Water activity determination is increasingly being used in the pharmaceutical industry as evidenced by a newly drafted USP <922> Chapter for Water Activity measurement. This webcast presents how a water activity measurement can be implemented to give insight into the impact of moisture on critical product quality attributes including stability, dissolution rate, and physical properties of tablets, pills, capsules, and other solid pharmaceutical material.

  • Webinar: Navigating EU Product Launch Milestones

    Throughout this webinar we will share our knowledge and experience of various EU regulatory filing options focusing primarily on the centralized procedure. This webinar will help you navigate the various EU regulatory filing options to allow you to plan ahead and save time in what can be a lengthy and complicated process.

  • Asahi Kasei Bioprocess’ Planova™ SU-VFC: Realizing Single-Use Technology In Virus Filtration

    This presentation discusses the advantages of going single-use, key design features of the system, automation benefits, and how to address some common challenges of single-use systems.