Government

WHITE PAPERS AND CASE STUDIES

• Understanding Biosafety Levels

  Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Gene And Cell Therapy: Planning For Manufacturing Success Early

  As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.

• Rethinking Clinical Operations: A Smarter, Faster Playbook For Trial Success

  The CRO-sponsor partnership is now strategic, addressing communication gaps and fragmented systems to improve efficiency. Joint governance, real-time tracking, and unified technology accelerate complex trial execution.

• Diving Into Smart Water Management

  Learn about a water management project that established a culture of innovation and smart water management for the coastal city of Porto. 

• 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.

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.