Records Management

WHITE PAPERS AND CASE STUDIES

• Building Excellence In Pharma Manufacturing Through Rigor

  A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• Compressed Air System Leaks: The Cost, Common Culprits, Detection, And Repair

  In this paper, we’ll discuss how many companies are losing thousands of dollars each year to compressed air system leaks. We will address where leaks commonly occur, leak detection methods, and practical advice for an audit and repair plan.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• Modernizing Operational Maintenance At Treatment Plants

  In 2017, the Harford County Division of Water and Sewer began looking for a modern work management solution to help automate preventive maintenance, coordinate work activities between groups, manage material inventories, and capture important data.

• Agentic AI And How It's Impacting Clinical Trial Research

  Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.

• Reducing ADC Timelines With Integrated Development And Manufacturing

  ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.

• Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

  Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

• Digital Transformation Optimizes Production, Quality, And Compliance

  Discover how advanced automation solutions at Fermion's new facility were implemented to enhance production, quality, and compliance in pharmaceutical manufacturing while meeting industry standards.

• Strategies For Post-Approval Lifecycle Management And Local PV

  If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.