Toxicology

GLP and Non-GLP Toxicology Programs Built for Speed, Clarity, and Confidence

At Envol Biomedical, we deliver toxicology studies that are fast, flexible, and fit for regulatory submission. Whether you're in early discovery or approaching IND-enabling milestones, our team provides robust, high-integrity toxicology programs rooted in nonhuman primate (NHP) models, regulatory compliance, and a relentless focus on sponsor outcomes.

Our toxicologists, study directors, and scientific team work side by side with clients to generate data that is clear, timely, and defensible—supported by full-service capabilities and vertically integrated resources.

Our Approach to Toxicology

Toxicology is more than a regulatory checkbox. At Envol, it’s a science-driven discipline that integrates:

Rigorous study design and execution
High quality biological assessments
Cutting-edge analytics and reporting
True responsiveness to shifting sponsor needs

We offer both GLP and non-GLP toxicology services, with a focus on speed to report, transparent communication, and scientific flexibility

GLP Compliance and Regulatory Readiness

We specialize in supporting IND-enabling toxicology with all necessary regulatory features:

GLP-compliant facility and processes
SEND-ready data output
LIMS enabled
Real-time reporting via Resero
Qualified study directors and toxicologists

Our team understands the criticality of timelines and the consequences of delays. That’s why we prioritize precision, proactive scheduling, and transparent updates throughout every study.

Specialty Endpoints and Cross-Functional Integration

Envol’s toxicology studies are not conducted in isolation—they are supported by a rich set of integrated capabilities:

Physiology & Functional Endpoints

We assess a broad array of physiological systems as part of our toxicology readouts:

Neurological
Respiratory
Cardiovascular
Gastrointestinal
And more

Where relevant, these assessments are combined with imaging, biomarker data, and clinical observations to provide a full picture of safety and tolerability.

Pathology Support

While histopathology is primarily outsourced, we provide:

In-study sample prep and coordination
Pathology reporting integration
Study director oversight across clinical, pathology, and reporting phases

AI-Enabled Reporting

AI platform allows for:

Real-time data transformation
Rapid turnaround on preliminary and final reports
Automated SEND datasets
Visual summaries for internal and external stakeholder review

Why Sponsors Choose Envol for Toxicology

IND-enabling study expertise
GLP, SEND, and LIMS-compliant workflows
Surgical dosing and functional endpoints
Resero-powered reporting & modeling
Rapid start-up and responsive communication

Whether you’re initiating a toxicology screen or preparing your final IND package, Envol delivers the scientific credibility, technical capability, and service-first approach you need to move forward—on time and with confidence.

Study Types and Toxicology Capabilities

We routinely conduct:

Repeat dose toxicology studies
Investigational and discovery-stage tox
Safety assessments across diverse administration routes
Studies incorporating CNS, ocular, respiratory, and cardiovascular endpoints

Our vertically integrated NHP colony, combined with in-house surgical expertise, gives us full control over animal sourcing, cohort matching, and specialized dosing—allowing us to adapt quickly and design smarter studies.

Supporting Capabilities for Toxicology

Toxicology studies at Envol are strengthened by:

Surgical Capabilities: Specialized dosing access (e.g., CNS, intrathecal, intranasal), serial sampling, implant placement
Core Laboratory Services:
- Clinical pathology (hematology, chemistry, coagulation, urinalysis)
- Immunology (cytokines, flow cytometry, ELISA)
- Ligand-binding assays
- ADA, PCR, ddPCR

These services are available on-site, reducing delays and enabling more efficient workflows across studies.