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WHITE PAPERS AND CASE STUDIES

• Relieving Pressure During Preparation Of A High-Volume sNDA

  Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• Modernizing Global Asset Management at Fujifilm Biosciences

  See how Fujifilm Biosciences unified global asset management to improve compliance, efficiency, and audit readiness through a validated, cloud-based life sciences platform.

• Navigating Sensitive Country Requirements

  See how Scout expertly navigated complex regional laws and regulations to allow study patients in Iran access to treatment in Turkey.

• ABB Helps New Zealand's Watercare Comply With New Fluoride Monitoring Regulations

  Discover why Watercare, New Zealand's largest water and wastewater utility company, engaged ABB and Water Engineers Limited to install and commission ABB Aztec AFM631 Fluoride Analyzers in their Auckland water treatment plants.

• Sol-Gel Builds Awareness Of Rare Skin Condition, Generates Leads

  Explore a 60-day HCP Awareness email campaign that surpassed industry benchmarks and generated a substantial number of leads.

• Supporting A CAR T-Cell Therapy Study In Hematologic Malignancies

  To address a life-threatening complication of immunotherapy in hematologic malignancies, a U.S. biotech company developed a novel compound.

• Unravelling Immunological Depths: Exploring Oxazolone-Induced Delayed-Type Hypersensitivity Model

  Validating the oxazolone-induced DTH mouse model offers a critical platform for advancing the evaluation of therapeutic candidates for chronic inflammatory diseases, including atopic dermatitis.

• End-To-End Clinical, Biometrics, And Regulatory Support In Neurology

  Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.

• Development To Large-Scale cGMP Production

  For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

• Asset Reinduction To Maximo EAM, Enabled By Reality Capture

  Find out how reality capture was used to create a digital twin 750,000-square-foot Pfizer campus to support asset reinduction to Maximo EAM, saving Pfizer 3,000 hours per year.

• Pasteurized Equivalent Water Treatment At High Desert Milk, Idaho, US

  Learn how High Desert Milk, a cooperative in Idaho, optimized their water treatment process using HOD™ UV technology, ensuring FDA compliance while significantly reducing water and energy consumption.