If you are looking for a complete program of GLP IND, veterinary and BLA-enabling regulatory toxicology studies for small and large molecules, devices, combination products, botulinum toxin, stem cells, vaccines, viruses and nanoparticles, CBI offers complete services. Your studies will be initiated rapidly and you can count on report preparation that will meet your deadlines or milestones.

We have completed successful IND packages in the areas of oncology, botulinum toxin, dermal, stem cells, cancer vaccines, IBD, atherosclerosis, metabolic disease, ocular and wound healing.

Our strength is providing toxicology packages for unusual or problematic test articles and indications or with aggressive timelines.

Regulatory Toxicology Studies

SPECIES

  • All species

ROUTES OF ADMINISTRATION

  • Standard routes
  • Intravesicular
  • Intravaginal
  • Intrarectal
  • Intranasal
  • Intradermal
  • Ocular
  • Aural-otic
  • Buccal
  • Patches
  • Devices
  • Device-drug combination
  • Infusion
  • Dermal
  • Topical
  • Wounds
  • Sublingual
  • Nanoparticles
  • Device stem cell combination
  • Intrathecal
  • Intracerebral
  • Intratumoral
  • Intracardiac
  • Intra-intestinal
  • Others upon request

TYPES OF TOXICOLOGY STUDIES

Acute Studies

  • Acute
  • Dose ranging
  • Limit dosing
  • Maximum tolerated dose
  • Single dose

Subacute & Subchronic

  • 1-week subacute
  • 2-week subacute
  • 4-week subchronic
  • 8-week subchronic

Chronic & Carcinogenicity

  • 3-month chronic
  • 6-month chronic
  • 9-month chronic
  • 1-year carcinogenicity
  • 2-year carcinogenicity

Special or custom toxicology

  • 1-year chronic
  • 2-year chronic
  • Stem cells
  • Surgical toxicity
  • Transgenic carcinogenicity
  • Others upon request