Government

WHITE PAPERS AND CASE STUDIES

• Development And Regulation Of Veterinary Monoclonals

  Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

• 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.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• How Manufacturers Navigate Labor Shortages, AI, And Quality Challenges

  Review a survey that reveals key industry challenges such as labor shortages, skills gaps, and safety risks, while also spotlighting AI adoption and rising investment in quality innovation.

• 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.

• 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.

• Severn Trent Exceeds Leak Reduction Targets With Innovative Itron Water Solutions

  Severn Trent’s smart metering program, powered by Itron’s technology, is transforming water conservation—reducing leaks by 6 million liters, cutting costs, and empowering customers to use water more wisely.

• A New, AI-Augmented Horizon For Safety And Pharmacovigilance

  Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• What Clinical Trial Decision Makers Are Prioritizing In 2025

  In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.

• 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.