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Business Details
26 Years
experience
Trusted Preclinical Research Services in Fort Collins
Colorado Histo-Prep is a preclinical contract research organization (CRO) dedicated to advancing biomedical research, pharmaceutical development, and medical device innovation. Established in 2000, we operate in full compliance with FDA, EPA, USDA, and OLAW regulations, offering high-quality in-vivo laboratory services across a diverse range of species, including rodents, companion animals, and large agricultural species. Our state-of-the-art facilities near Fort Collins, Colorado, feature specialized surgical equipment and modern ventilation systems to ensure sterility and efficiency. With over two decades of experience, our team of toxicologists, pathologists, and regulatory specialists provides tailored study designs, expedited turnaround times, and direct communication with study directors to meet global regulatory requirements.

We prioritize humane research practices, maintaining facilities that meet or exceed European Union animal welfare standards. Our clients range from small biotech startups to multinational pharmaceutical companies, benefiting from our expertise in protocol development, pharmacokinetics, toxicology, and safety pharmacology. We emphasize transparency, client collaboration, and scientific rigor to support successful product development and regulatory approval.
Services
PK/TK Studies Toxicology Studies ADME Studies Safety Pharmacology Histopathology
Details
  • Year established: 2000
Highlights and features
  • We offer 20+ years of experience in FDA/EPA/USDA-regulated preclinical research.
  • Our facilities meet European Union animal welfare standards for international compliance.
  • We provide expedited turnaround times for time-sensitive drug and device development.
  • Our team includes certified experts in toxicology, pharmacokinetics, and regulatory affairs.
  • We maintain a modern surgical facility with specialized diagnostic equipment.
Associations and certifications
  • USDA
  • OLAW
Services
PK/TK Studies
Pharmacokinetic (PK) and toxicokinetic (TK) studies support drug discovery through single- and repeat-dose testing in rodents and non-rodents. We offer rapid turnaround times, flexible protocol adjustments, and standardized reporting to meet aggressive timelines for outsourced programs.
Toxicology Studies
We conduct acute, subchronic, and chronic toxicity studies to evaluate adverse effects of substances. Our services include dose selection, target organ identification, and regulatory compliance for FDA, USDA, and EPA submissions using diverse animal models.
ADME Studies
ADME (Absorption, Distribution, Metabolism, Excretion) studies assess compound viability for clinical trials. Custom-designed protocols in multiple species provide data on metabolic pathways, bioavailability, and excretion rates to inform drug development decisions.
Safety Pharmacology
Our safety pharmacology evaluations identify potential risks in nervous, cardiovascular, and respiratory systems. Non-GLP pilot studies and GLP-compliant assessments help clients determine safe dosing for clinical trials.
Histopathology
In-house histopathology services include tissue collection, processing, and microscopic evaluation. Board-certified pathologists provide detailed reports on treatment-related changes to support regulatory submissions and study conclusions.
Questions
What types of preclinical studies does Colorado Histo-Prep offer?
We provide PK/TK, toxicology, ADME, safety pharmacology, and histopathology studies in compliance with GLP and non-GLP standards.
Which regulatory agencies does Colorado Histo-Prep work with?
Our studies support FDA, EPA, USDA, and international regulatory submissions through rigorous compliance and documentation practices.
What animal models are available for research?
We use rodents (rats, mice), rabbits, canines, swine, sheep, poultry, and large farm animals for diverse study requirements.
How does Colorado Histo-Prep ensure animal welfare?
Our facilities exceed USDA and OLAW standards, with housing environments designed for species-specific needs and humane treatment protocols.
Can Colorado Histo-Prep handle time-sensitive projects?
Yes, we offer expedited timelines through rapid study initiation, flexible scheduling, and abbreviated reporting methods for urgent needs.
Where is Colorado Histo-Prep located?
Our modern surgical and research facilities are located near Colorado State University in Fort Collins, Colorado.