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Drug Development Services

No matter what special requirements and timelines you may have, BASi scientists customize an array of GMP, GLP or non-GLP CRO services to meet the unique demands each client project requires. We establish strong lines of communication, both from a technical and business perspective, to assure the success of each project.

CRO Services

Bioanalytical Services (including GLP)

  • Discovery, non-clinical and clinical bioanalytical support
  • Large and small molecule capability
  • Biomarker assays
  • High capacity, fast turnaround sample analysis (Phase 1 support)
  • FIM and Phase I support
  • Automated sample analysis
  • Cutting edge technology: LDTD source and Dried Blood Spot analysis
  • All systems Part 11 compliant
  • PK kit manufacturing

Non-clinical/GLP Toxicology Services

  • IND enabling studies
  • Non-clinical animal studies
  • Pathology service
  • Rodents, rabbits, dogs, swine, monkeys and others
  • All dose routes except inhalation
  • In-house dose preparation and analytical support

Discovery Research Services

  • Research/Discovery experiments: efficacy, target validation, new compound screening
  • PK/TK, optionally utilizing BASi’s proprietary Culex® system
  • Automated simultaneous dosing and sampling from conscious freely-moving animals (rodents, dogs, and monkeys)
  • Real time data from stress free animals reduces the number of animals used
  • Samples: blood, bile, urine and feces
  • Automates in-vivo microdialysis sampling from blood and tissues
  • Lead optimization allows real time in-vivo ADME experiments

Pharmaceutical Analysis and Stability Program Management (including GMP and GLP)

  • Formulation through post-market sample analysis
  • Method development, validation, revalidation, transfer
  • Stability support, lot release and comparator testing
  • Potency, purity, dissolution, water, physical testing
  • Stability storage
  • Medical device testing
  • In vitro bioequivalence analysis