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iuvo BioScience is a contract research organization serving the pharmaceutical and medical device industries. With a focus on safety and biocompatibility, iuvo provides assistance through the full product development life cycle, from research to release, including ISO 10993 testing as well as testing programs and advisory services to support regulatory submissions. We have an AAALAC-accredited vivarium and offer full service, GLP-compliant toxicology, microbiology and analytical chemistry testing laboratories along with comprehensive consulting services. We bring decades of experience supporting healthcare companies, and we work closely with our customers to delivery exquisite science, reliably and on time.
Come to us with a specific test, a full program you need managed, or even a research question you need help answering. We are your Partner Research Organization.

Technical Information:

Full-service, AAALAC-accredited small animal vivarium (mouse, rat, guinea pig, rabbit, etc.) capable of conducting the full battery of the in-vivo testing required by ISO-10993 as well as a number of pharmaceutical studies (i.e. dose ranging studies, PK/TK, sub-chronic and chronic toxicology studies, rodent portion of IND-enabling studies, ocular irritation, lens wear studies, etc.) under GLP and non-GLP conditions

Full analytical chemistry capabilities to support medical device and pharmaceutical product development (HPLC with multiple detectors, GC, GC w/ headspace, GC/MS, FTIR, ion chromatography, USP / compendial release capabilities, TOC / conductivity, osmolality, contact lens compatibility testing, lens uptake / release, material compatibility, etc.)

Multiple ICH Stability Chambers

Full service microbiological laboratory (sterility testing, bioburden, preservative effectiveness testing - PET, antimicrobial effectiveness testing - AET, environmental monitoring, regimen testing, biocidal testing, biofilm capabilities, minimum inhibitory concentration (MIC) testing, virus / virology, etc.)

Aging / packaging chambers with associated testing (creep-to-burst, blue-dye test, peel strength, microbial ingress, etc.)

BSL-1 and BSL-2 capable

 In-vitro toxicology / cytotoxicology (MEM elution, direct contact, agar diffusion, V-79 and other colony-forming assays, etc.)

Genetox capabilities (Ames assay, In-vivo micronucleus, PIG-A)

Bacterial endotoxin testing

Significant consulting services in pre-clinical toxicology, quality, chemistry, microbiology, CMC, regulatory strategy (IND, NDA, 505(b)(2), IDE, 510(k), PMA as well as international expertise) for the medical device and pharmaceutical industries



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