Document Migration

WHITE PAPERS AND CASE STUDIES

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Why An Integrated Approach Ensures Smooth Entry Into The European Market

  Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.

• 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.

• Building A Legacy In Sterile Injectables Through Strong CMO Synergy

  Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.

• Yorkshire Water Reduces Leaks By 57%, Eliminating 30% Of Annual Distribution Main Repairs

  Yorkshire Water Services (YWS) is a leading UK water utility that serves nearly 5.5 million people and has a well-deserved reputation as a progressive and proactive utility. Their belief that innovation is one of the key driving forces that allows utilities to deliver better services to their customers while keeping costs down has led them to always seek out new ways to improve their operations both now and in the future.

• 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.

• 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.

• Using Precision Fermentation To Produce Animal-Free Milk Proteins

  Learn about an innovative approach to producing animal-free milk proteins using precision fermentation technology supported by bioreactors,  offering an ethical alternative to traditional dairy production.

• Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

  Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

• From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer

  Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.

• Key AI Trial Insights From Regulators And Consultants

  AI’s transformative impact promises more efficient, cost-effective, and successful clinical trials across the pharmaceutical landscape.

• 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.