Document Migration

WHITE PAPERS AND CASE STUDIES

• ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials

  Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

• Modern Modeling Tools For Small Molecule Solid Dose Manufacturing

  Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

• How Bend Bioscience Standardized Operations And Boosted Compliance

  Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

• A Synergy Of Excellence: Partnership During Unprecedented Times

  Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

• The Future Of Regulatory Operations

  The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

• Meet Regulation Requirements With RTU Vials And Cartridges

  Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.

• 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

• The GxP Digital Maturity Model

  Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.

• Transforming Environmental Monitoring And Sample Management

  Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.