3. We have the experience you need!
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Unparalleled Regulatory Guidance >> to ensure unhindered FDA/EPA/OECD acceptance
Specialized Expertise & Facilities >> to conduct studies effectively
Small & Large Animal Species>> to customize studies & meet unique needs
Depth of Experience >> to conduct studies efficiently and humanely
Responsive Updates & Feedback >> to provide guidance for mid-course adjustments
We treat your project like it’s our own
4. Comprehensive guidance from start to finish
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Experienced study
directors involved
throughout
Expert protocol
development process
Accelerated IACUC
Approval
Able to meet aggressive
timelines
Large library of
standard studies
Standardized reporting
methods
Continuous study
progress updates
Experienced
Regulatory Review
6. Well-rounded experience we can leverage
Over 150 years of combined experience conducting
toxicology studies
Distinguished IACUC Committee involvement (to
deliberate and approve projects on ongoing basis)
Track Record of Receiving Approval for Several IND &
NDA Enabling Studies
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7. Wide range of capabilities
■ PK/MTD to DART studies
■ Custom Medical Device preclinical studies
■ 510K to IND/IDE submission regulatory guidance
■ IND/NDA Enabling studies
■ Multi-functional capabilities spanning in vivo models, surgeries, clinical
and histopathology
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10. Outdoor Pastures - Large Farm Animals, Equine to Swine
Indoor Facilities – Rodents to Dogs
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11. Species of focus (GLP & non-GLP)
Acute to chronic toxicity
Pharmacokinetic / Toxicokinetic
models
Reproductive/ developmental
toxicology
Special models (arthritis,
respiratory, in-vivo
biocompatibility)
Ocular Implants
Dermal sensitivity
Acute/chronic toxicity
Pharmacokinetic / Toxicokinetic
models
Surgical device development
Feed/nutrition
Wound Healing
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Acute to chronic toxicity
Pharmacokinetic / Toxicokinetic
models
Surgical models
Gait analysis
Efficacy
MTD
SMALL LARGE
S
t
u
d
y
T
y
p
e
s
Mice, rats, ferrets, rabbits, hamsters,
guinea pigs, etc.
Dogs, cats, horses, etc. Porcine, Equine, Bovine, Ovine, Poultry, etc.
13. Case studies - Drugs
■ Neurotropic Drug – DART/NDA Enabling, allowed Phase-3 Clinical
Trials
■ Ophthalmic Biologic- Resulted in Approval of Phase-2 Clinical Trials
with Minimal Testing
■ Nasal Delivery
■ Ocular Drug Delivery
■ IBD Models
■ 5 Different Drugs for Separate Clients Taken off Clinical Hold
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14. CSU Department of Lab Animal Resources
CARE & CSU LAR Relationship
Interinstitutional Agreements
World Class Veterinary Expertise/Collaboration
Shared IACUC members reduce regulatory delays
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