Our Services

Non-Clinical Support

Bridging Science and Strategy for Smarter Development


Our non-clinical support services are designed to ensure your early development program is scientifically sound, regulatory-ready, and strategically aligned for success. Whether you're entering IND-enabling stages or refining your preclinical roadmap, our expert team provides end-to-end support across all non-clinical functions.


What we offer:


  • Project Monitoring & Management

Proactive oversight of non-clinical studies, ensuring timelines, data quality, and study execution stay aligned with your program goals.


  • Toxicology Subject Matter Experts (SMEs)

Access to highly experienced toxicologists with domain expertise across a wide range of therapeutic areas—offering guidance on study design, interpretation, and regulatory strategy.


  • GLP Compliance Support

We support your Good Laboratory Practice (GLP) requirements through:

- On-site and remote GLP inspections

- Study monitoring for adherence to regulatory expectations

- SOP review and preparation to align with industry standards


  • Laboratory Selection & Vendor Analysis

We help you make informed outsourcing decisions through comprehensive SWOT analyses of laboratory vendors—balancing scientific capabilities, compliance history, cost, and timelines.


  • Protocol & Report Development

Our team supports the design and review of:

- Non-clinical toxicology protocols

- Study designs tailored to regulatory and scientific goals

- Draft reports with scientific rigor and submission readiness


  • Impurity Assessment & Qualification

We help evaluate and qualify impurities through data-driven strategies, supporting CMC and safety submissions with scientifically justified assessments.


  • Literature-Based Safety Reviews & Risk Assessments

Our scientific writers and toxicologists perform comprehensive literature-based reviews to support risk evaluations, white papers, and regulatory briefing documents.




Our team understands that robust non-clinical foundations are critical to long-term success. We bring the scientific depth, regulatory foresight, and operational agility needed to guide your program from discovery through IND submission—efficiently, compliantly, and with strategic clarity.

Whether you're a virtual biotech or scaling toward clinical readiness, we're here to help you move forward with confidence.