INSIGHTS ON REGULATORY COMPLIANCE

• Operational Readiness In Pharma

  Operational Readiness bridges project delivery and GMP manufacturing to ensure systems and teams are prepared for execution. Discover how a digital validation platform streamlines this transition.

• The CMC Regulatory Landscape During Product Development, Manufacturing

  Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services and strategic guidance.

• A Practical Packaging Components Checklist For Emerging Biotechs

  A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

• FAQs On The Revised EU GMP Annex 1: Volume 2

  Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

• Your Global Partner In Pharmaceutical Contamination Control

  6/24/2025

  Ensure cleanroom compliance with an expert team that helps you interpret critical data, align with global regulations, and maintain control through proactive contamination strategies.

• Aseptic Expertise And Delivery Of Services

  8/20/2024

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

• Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections

  12/20/2023

  Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.

• Inside A Collaboration To Design Cutting Edge Modular Cleanrooms

  1/31/2025

  Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

• Label-Free Analysis Of Multiple Spheroids In A Matrix

  11/7/2025

  Gain insight into how automated z-stack imaging and AI-based analysis enable accurate, label-free monitoring of spheroid development in 3D matrices for drug screening and cell culture workflows.