Charting a course for
Innovative Drug Discovery
Designing and Executing Preclinical Safety & Toxicology Studies with Precision
About Us
Navegador Biosciences is a partner specializing in the design and execution of high-quality preclinical studies from early discovery to regulatory-enabling safety and toxicology studies. With deep expertise spanning all stages of drug development, we help bridge the gap between scientific innovation and clinical readiness.
Our team combines scientific rigor with regulatory insight to accelerate drug development timelines and de-risk the path to first-in-human trials. Every study we conduct is aligned with ICH and GLP standards and tailored to meet the specific needs of emerging biotech and pharmaceutical companies.
We offer strategic support in dose selection, risk assessment, and biomarker integration — enabling our partners to generate the robust data packages required for regulatory submissions and investor confidence.
At Navegador, we don’t just run studies — we navigate your program toward success.
With deep expertise across discovery and preclinical stages of drug development, we deliver compliant, fast-moving, and regulator-ready programs designed to translate into successful clinical outcomes.
Proven expertise across early discovery and late preclinical stages of drug development, accelerating translation to regulatory toxicology and early clinical trials
Deep understanding of the regulatory landscape enables strategic optimization of preclinical programs
All studies conducted under ICH Guidelines and GLP standards, ensuring global regulatory alignment
Rapid study initiation and compressed timelines to support critical development milestones
Rigorous risk assessment for clinical dose selection, improving safety and development confidence:
Biomarkers
Custom development of target engagement and biomarker assays
Integration
Inclusion of target engagement and biomarker readouts in toxicology studies support dose selection for clinical trials.
Risk Assessment.
Quantification of safety margins between toxicity and therapeutic efficacy. Monitorability and reversibility of the observed toxicity.
Safety and toxicology studies
General toxicology:
Single Ascending Dose studies;
Dose Range Finding studies;
Single dose (acute) studies;
Extended Single Dose studies;
Repeat-dose studies in rodents (up to 6 months) and non-rodents (up to 9 months).
Safety Pharmacology:
Cardiovascular system (telemetry in non-rodents, hERG inhibition);
Respiratory system;
CNS (Functional Observation Battery, Irwin test).
Genetic Toxicology:
AMES test;
Chromosomal Aberration Assay;
Mouse Lymphoma Assay;
Micronucleus Test;
PigA Assay.
Animals: mice, rats, rabbits, dogs, non-human primates.
Reproductive Toxicology:
Fertility and Early Embryonic Development;
Embryo-fetal Development;
Pre- and Post-natal Development.