At Veloxity Labs, quality is not a checkpoint at the end of the workflow. It is built into the operational disciplines that guide how studies are designed, executed and reported every day.
Quality in regulated bioanalysis is more than compliance with GLP, GCP and ICH M10 expectations. Quality depends on the operational disciplines that guide method development, data review, documentation and study oversight throughout the laboratory workflow. Routine audits and best-in-class systems ensure speed never comes at the expense of data integrity. With deep regulatory expertise and industry leadership, our QA function is purpose-built to support confident decision-making and accelerate your development timelines.
Quality and data integrity in bioanalysis are shaped by the operational disciplines that guide how laboratories work every day. This report examines the practices that influence reliability, regulatory alignment and predictable timelines in modern bioanalytical laboratories, drawing on real-world experience from regulated LC-MS workflows. Explore the six disciplines that help laboratories deliver accurate, inspection-ready data while keeping development programs moving forward.
Audit-ready by design, our systems and processes are built to meet the highest standards of transparency and traceability. Our proprietary VELO™ workflow platform enhances QA oversight, enabling proactive issue resolution and seamless collaboration with your team.
Explore how automated data workflows elevate the value of QAU audits in our latest report.
The latest FDA guidance on biomarker bioanalysis represents progress—but leaves key gaps around context of use, assay coverage and validation clarity. These ambiguities raise the risk of inconsistent data and regulatory missteps, particularly for novel biomarkers. With over 75 years of combined experience, Veloxity Labs helps sponsors interpret guidance, validate with confidence and accelerate development.
Download the full report to explore actionable insights and how we can support your biomarker strategies under the 2025 FDA framework.
Veloxity’s QA leaders don’t just follow evolving regulations—they help shape them. In collaboration with the Center for Veterinary Medicine (CVM), Director of QA Chris Tudan, PhD, helped secure ICH M10 acceptance for animal health studies. Our latest report breaks down the newly released 2025 FDA Biomarker Guidance, highlighting critical gaps and how to stay ahead.
Download the full report to learn how our team can help validate your biomarker assays with scientific flexibility and regulatory precision.
High-quality bioanalysis depends on consistent operational practices across the laboratory workflow. This infographic provides a visual overview of the six disciplines discussed in our report, highlighting how these practices support data integrity, regulatory alignment and efficient study execution.
