Regulatory

  1. Selecting Container Closure Components: Extractables And Leachables

    Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.

  2. EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

    Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

  3. Navigating GxP Compliance Challenges 10/30/2024

    Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

  4. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  5. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

    The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.