Insights On Regulatory Compliance

1. Compound Library Consortium 5/16/2024

   Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.

2. Driving Continuous Improvement: Pushing Through The Barriers To Change 10/15/2024

   Discover how continuous improvement drives efficiency in pharmaceutical manufacturing. Learn strategies to harmonize processes and reduce environmental impact in this thoughtful exploration.

3. Overview Of Biological Indicator And Sterilization Monitoring Systems 7/2/2024

   Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.

4. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

   One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

5. Move Beyond Manual CQV Challenges With Digital Solutions 1/24/2025

   Review how digitalizing commissioning, qualification, and validation (CQV) with a new software streamlines processes, enhances compliance, and reduces time to drive efficiency and sustainability.

6. A Blueprint For Avoiding FDA Recalls 10/9/2024

   Avoid FDA recalls and safeguard your life sciences business. Learn how QMS and EBR/eDHR solutions can prevent costly product recalls and ensure compliance with FDA regulations.

7. 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.

8. Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization 8/25/2023

   There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

9. Rising Sun: The Drug Pricing Environment In Japan Is On The Up 3/18/2025

   Japan’s recent pharmaceutical pricing reforms present new opportunities for the industry, fostering innovation while aiming to ensure faster access to treatments.

10. Introduction To The 3 Pillars 8/1/2023

    To optimize and standardize cell line development that benefits downstream work, organizations must focus on technology and expertise in three key areas: automation, analytics, and digitalization.