At the intersection of advanced data science, regulatory science, and precision analytical chemistry, Nuraxs is proud to announce its official launch.

Born out of a need to drive faster, smarter decisions in the biologics space, Nuraxs introduces a fundamentally new approach to solving some of the most challenging problems in biopharmaceutical development—stability, manufacturability, and product quality.

Why Nuraxs?

The life sciences industry has witnessed unprecedented innovation in therapeutic modalities—antibody-drug conjugates (ADCs), gene therapies, mRNA vaccines, and engineered proteins. Yet, the analytics and stability strategies supporting these therapies have lagged behind.

Traditional methods often rely on retrospective data and lengthy ICH-based studies. Nuraxs was founded to redefine what’s possible by introducing predictive intelligence into the earliest stages of biopharmaceutical development.

Our Mission

To empower analytical, formulation, and regulatory teams with AI‑powered tools that anticipate degradation, de-risk product failures, and accelerate CMC timelines—especially for novel modalities.

We do this by combining deep experimental ground-truth data from GMP laboratories with proprietary AI models that forecast long-term product behavior under real-world and accelerated conditions.

The Founding Vision

Nuraxs was co-founded by:

• Umesh Dangat, a systems thinker and AI product strategist focused on unlocking decision-making through data architecture and modeling.
• Kenneth Gomez, a leading figure in analytical development within the biopharmaceutical industry.

Together, they envisioned a platform that turns every experiment into a feedback loop—allowing CMC and regulatory strategies to benefit from prediction, not just observation.

What We Offer

Nuraxs is launching with a portfolio of solutions, including:

• Arrhenius Edge™: Our flagship AI engine that models temperature- and humidity-based degradation kinetics using GMP lab data—predicting product shelf-life, formulation stability, and comparability outcomes in a fraction of the time required by traditional methods.
• Nuraxs Data Vault™: A secure, regulatory-ready architecture to organize, tag, and analyze multimodal data from HPLC, CE, ELISA, iCIEF, and more.
• CMC Scenario Forecasting Tools: Simulate what-if stability and manufacturing conditions using our proprietary models to optimize fill-finish, storage, and supply chain decisions.

Who We Serve

Whether you’re a venture-backed startup looking to de-risk your IND-enabling studies, or a global biopharma seeking efficiency in your comparability or bridging studies, Nuraxs delivers value at every point in the drug development lifecycle.

What’s Next

We are actively forming strategic partnerships with:

• CDMOs and testing labs
• Biotech startups and accelerators
• Regulatory consultants and CMC teams
• University spinouts developing novel therapeutics

If you’re interested in working together—or learning how our models outperform static models or retrospective stability databases—we’d love to hear from you.

🔗 Visit www.nuraxs.com
📧 Email info@nuraxs.com