Insights On Regulatory Compliance

  1. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  2. What Indications Can, And Will, mRNA Therapeutics Address? 12/5/2023

    During our Bioprocess Online Live event, mRNA Update: Beyond Prophylactic Vaccines, we asked an audience of several hundred biopharma professionals what indications they’re addressing in mRNA therapeutic development. Here, our panelists address their responses and offer final thoughts on unfolding mRNA regulatory frameworks.

  3. Normalized Data In Microbial Continuous Monitoring 7/24/2025

    Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

  4. Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance 6/6/2024

    Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

  5. Navigating The Paradigm Shift: Ensuring Efficacy In Risk-Based Cleaning Validation 10/23/2024

    Unearth how adopting a risk-based approach to cleaning validation can enhance product quality, safety, and regulatory compliance in pharmaceutical manufacturing.

  6. Safely Navigating The Transition From MDD To MDR 7/25/2025

    If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

  7. Service Solutions Designed To Help You Gain Speed To Clinic And Market 4/28/2025

    Discover how speed, cost, and regulatory acceptance impact drug manufacturing, as well as learn about aseptic filling challenges and how innovative services can enhance your efficiency and compliance.

  8. Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing 5/12/2025

    A successful large-scale public health emergency response requires adaptable manufacturing capabilities, an experienced workforce, and effective private-public partnerships.

  9. Sustainability By Design In API Manufacturing 7/29/2025

    Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.

  10. 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.