Comparative Biosciences@2X

Trusted Toxicology Expertise to Guide Your IND Journey

Comprehensive Toxicology Services for IND-Enabling Studies

Ensuring the safety and efficacy of your investigational new drug (IND) is critical. Our contract research organization (CRO) offers a full suite of toxicology services to support your drug development process with precision and compliance.

IND-Enabling Study Expertise

Our team provides in-depth toxicology studies to meet regulatory requirements and accelerate your IND submission.

  • Acute, subacute, subchronic, and chronic toxicity studies
  • Dose-response, tumorigenicity, and carcinogenicity assessments
  • Specialized studies in tumor-bearing animal models
  • Pharmacokinetic and toxicokinetic evaluations
  • Immunogenicity assessments
  • Systemic and ocular biodistribution analysis
  • SEND-formatting for regulatory submission
  • GLP-compliant data archiving
  • TCR studies for antibody research
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OECD TG Study Expertise

We adhere to the highest international standards, following OECD Test Guidelines (TG) to ensure regulatory compliance and data integrity.

Type of Test Article

  • Chemical Compounds
  • Biologics
  • Cell and Viral Products
  • Nanomaterials Medical Devices**
  • Others

ROA

  • Oral Gavage
  • Subcutaneous
  • Intra-peritoneal
  • Intravenous
  • Intramuscular
  • Intra-articular
  • Intra-dermal
  • Intra-tracheal
  • Intravitreal
  • Intracranial
  • Intranasal
  • Intratumoral
  • Intracameral
  • Subretinal
  • Osmotic pumps
  • In-Diet Administration
  • Implants
  • Inhalation

Requirements for IND 

Non-GLP:
  • Tolerability study
  • Efficacy studies
  • Dose-Response
  • Systemic PK
  • Ocular PK
GLP:
  • Acute toxicity
  • Subacute toxicity
  • Sub-chronic toxicity
  • Chronic toxicity
  • Toxicokinetic studies
  • Systemic PK
  • Systemic biodistribution
  • Tumorigenicity
  • Carcinogenicity
  • Genotoxicity*
  • Reproductive toxicity*
  • Teratogenicity*

Endpoints

During In-Life
  • Cage site clinical Obs
  • Detailed clinical Obs
  • Food consumption
  • Body weight
  • Body temperature
  • Ophthalmology (Ocular) exam
  • Other measurements
  • Telemetry*
Post In-Life
  • Necropsy and organ weights
  • Histopathology
  • Clinical pathology (Hem/ Chem)
  • Urine analysis
  • qPCR
  • Bioanalytical Testing
  • Biochemistry Testing
  • SEND formatting
  • Archiving

*Not provided by GD3 and may not be required for IND application
** Medical devices have different regulatory paths and may not require all of the IND-enabling studies

CBI is an industry leader in conducting difficult and unique IND-enabling research studies!

Over 25 years of experience in a broad range of innovative preclinical and translational research

Highly educated and experienced scientific team

Established collaboration with industry professionals and subject matter experts, particularly for niche and highly technical projects

Located in the heart of Silicon Valley, surrounded by prominent biotech, pharmaceutical, and medical device companies, academic centers, and governmental agencies

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Our Standards of Excellence

Ready to enhance your research with expert toxicology support?

CONTACT OUR TEAM

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