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Wednesday, August 20, 2008

Ensure the success of your drug development program with comprehensive program management

XenoBiotic Laboratories (XBL) has established a network of CRO partners and industry-networked consultants enabling us to provide comprehensive program management services from the earliest phases of in vitro and preclinical testing, to advanced clinical analysis - a program designed to speed your progress towards regulatory approvals.

Allow XBL to integrate a package of product development services into a comprehensive program that will drive your new product development. XBL stands ready to assist with individual projects, or coordinate complex multi-disciplinary programs that are necessary to demonstrate the purity, safety and efficacy of your lead compounds.

  • Chemical library screening
  • Organic synthesis, radiosynthesis
  • Toxicology
  • In vitro/in vivo ADME
  • Pharmacokinetics/toxicokinetics
  • Organic and analytical chemistry
  • Clinical and hematological assay
  • Bioanalytical method development and validation
  • Bioanalytical assay of preclinical and clinical samples
  • Phase I-IV clinical trial management (USA, Asia, Europe)
  • Regulatory Affairs support for product approval and registration worldwide (INDs, NDAs, ANDAs)

 

“XBL will work with you to assess your drug development needs and provide a custom fit solution.”