Preclinical and Specialized Testing
CEBIS USA manages and coordinates preclinical and specialized testing through qualified GLP facilities within its affiliate network. Services include preclinical studies, agrochemical testing, chemical testing, and GLP quality and compliance support.
Preclinical, Agrochemical,
Preclinical Studies
Toxicology and supporting preclinical activities for development programs, including safety, metabolism, pharmacokinetic and bioanalytical work where applicable.
Agrochemical Testing
Regulatory testing activities supporting agrochemical safety and registration programs.
Chemical Testing
Testing aligned with relevant chemical safety and registration requirements.
GLP Quality & Compliance
Quality-focused coordination and oversight for studies conducted through qualified facilities.
Preclinical Testing Supporting
General & Repeat-Dose Toxicology
Support acute, sub-acute, sub-chronic and chronic toxicology requirements where appropriate to the program.
Genotoxicity
Support appropriate in-vitro and in-vivo genetic toxicology testing.
Developmental & Reproductive Toxicology
Support studies addressing fertility, embryonic development and pre-/post-natal development where required.
Drug Metabolism & Pharmacokinetics
Support evaluation of metabolism and pharmacokinetic behavior during preclinical development.
Bioanalysis & Analytical Support
Coordinate analytical and bioanalytical activities supporting preclinical study objectives.
Method Development & Validation
Support development and validation of methods required for relevant study activities.
Testing Selected Around
the Development Program
- Acute toxicity
- Repeat-dose toxicology
- Sub-acute and sub-chronic studies
- Chronic toxicology
- Carcinogenicity where applicable
- Skin sensitization
- Developmental and reproductive toxicology
- Genotoxicity
- Toxicokinetic / pharmacokinetic support
- Relevant bioanalytical activities
Genotoxicity Testing Within
Preclinical Safety Programs
CEBIS can coordinate appropriate genotoxicity testing based on the development program, applicable test strategy and qualified facility capabilities.
Potential study categories can include:
- Bacterial mutation testing
- In-vitro mammalian testing
- Chromosomal-damage assessment
- Gene-mutation testing
- Micronucleus testing
- Appropriate in-vivo follow-up where required
Regulatory Testing for
Agrochemical Programs
Testing areas can include:
Physicochemical Testing
Characterization and testing relevant to the product and registration program.
Toxicology
Acute, repeat-dose and other appropriate toxicology evaluations.
Genetic Toxicology
Testing relevant to mutagenicity and genotoxicity requirements.
Developmental & Reproductive Studies
Appropriate DART testing where required.
Ecotoxicology
Evaluation of potential effects on relevant environmental organisms.
Toxicokinetics
Assessment of exposure and disposition where applicable.
Environmental Fate
Testing related to behavior in water, soil or air and bioaccumulation where required.
Testing Aligned With Chemical Safety and Registration Needs
- Physicochemical characterization
- Genetic toxicology
- Toxicokinetics
- Analytical support
- Toxicology
- Ecotoxicology
- Environmental behavior
- Other study-specific testing based on applicable requirements
Final study scope should be selected around the product, target market and applicable regulatory pathway.
Quality Oversight
for Specialized Testing
Preclinical and specialized studies may need to be performed under applicable Good Laboratory Practice requirements.
CEBIS coordinates these activities through its affiliate network and can align study planning with qualified facilities and appropriate quality processes.
Quality support can include:
- Selection and qualification of appropriate facilities
- Defined study documentation
- Controlled study processes
- Quality review
- Study oversight and communication
- Issue follow-up
- Support for final documentation
One Point of Coordination
CEBIS manages and coordinates preclinical and specialized testing through qualified facilities within its affiliate network.
Based on program needs, coordination can connect:
- Study requirements
- Appropriate testing capability
- Facility selection
- Study planning
- Analytical support
- Quality oversight
- Study documentation
- Sponsor communication
- Program Need
- Qualified Facility
- Study Execution
- Quality Review
- Results
From Preclinical Work
For pharmaceutical development programs, preclinical activities can form part of the evidence used to support decisions about subsequent clinical development.
Where appropriate, CEBIS can connect specialized testing with its broader capabilities in:
Need Preclinical or Specialized Testing Support?
Tell us about the product, development stage, testing requirements, target regulatory market and expected timeline. A member of the CEBIS team can discuss the appropriate testing and coordination approach.