INSIGHTS ON REGULATORY COMPLIANCE

• Biofluorescent Particle Counters Are Gaining Momentum

  The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

• Successful Regulatory Submission Via The Trifecta Of Awesomeness

  Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

• The Synergistic Role Of Drug Safety In Clinical Trial Operations

  Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

• Overcoming Hurdles With A Contamination Control Strategy

  Learn about the importance of a facility-specific CCS, explore common hurdles encountered in its development and get practical advice on creating a robust and compliant strategy.

• Harnessing The Power Of AI In Health Evidence Generation Strategy

  10/21/2024

  Explore applications and limitations for artificial intelligence (AI) in healthcare as decision-makers determine whether to adopt the software in their environments.

• Accelerated Tox Offerings: A Recipe For Streamlining IND Applications

  4/22/2025

  Accelerating the timeline to tox material can significantly enhance the drug development process, enabling faster IND submissions and providing crucial time savings for toxicology studies.

• Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological Cleaning

  10/10/2024

  Issues related to cleaning and cleaning validation are some of the most common concerns that arise in FDA Warning Letters. Discover how to ensure you pass your cleaning validation tests.

• Don't Skip Preformulation: Your Blueprint For Drug Development Success

  9/22/2023

  Investing in the right preformulation studies and gathering evidence to inform decisions is critical to identify product dead-ends and failure modes without the pain of hindsight.

• Navigating The Future Of Lab Developed Tests

  3/14/2025

  Explore the pivotal role of lab-developed tests (LDTs) in medical diagnostics, their growing regulatory scrutiny, and their future trajectory in modern healthcare to advance patient care.