Insights On Regulatory Compliance

  1. EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging 8/27/2024

    Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

  2. 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.

  3. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.

  4. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing 8/22/2024

    Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

  5. Navigating The Evolution Of EU Health Technology Assessment (HTA) Regulation 5/9/2025

    The future of pharmaceutical access in Europe is being shaped by the new EU HTA regulation. Insights from Pharma 2025, featuring Herbert Altmann and Alexander Natz, shed light on this pivotal shift.

  6. Revolutionizing Pharma Validation With AI 5/28/2025

    Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

  7. Integrated Approach In Managing CPV And APQR 11/12/2024

    Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

  8. Comprehensive Regulatory Support 8/29/2024

    Review our expertise across a wide range of global markets. Our experience in securing regulatory approvals and navigating market challenges positions us as a trusted partner.

  9. Does My Cleanroom Facility Need A Residue Removal Step? 3/28/2024

    Explore the challenges presented by the residues left behind by disinfectant solutions in cleanrooms as well as effective strategies for their management.

  10. Simplify CAPA In 7 Steps 9/20/2024

    Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.