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QSCL has 4 experts in safety evaluation and nonclinical drug development.

Therapeutic areas

  • Anti-inflammatories
  • Anti-infectives
  • CNS and oncology
  • COPD, smoking cessation, e-cigarettes
  • Topical routes: nasal, inhalation, ophthalmic and buccal

Product areas

  • New Chemical Entities and Existing Entities for generics and change of use
  • Reformulations & excipients
  • Impurities including extractables & leachables, and genotoxics
  • Biologics

Technical advice

  • Advise on design, conduct and interpretation of nonclinical toxicology studies
    • including safety pharmacology studies
  • Outsourcing to CROs and ensuring conduct to the appropriate standard
  • Member of Client Development Teams
  • Compliance with international regulatory guidelines

Toxicological reviews

  • Calculation of Permissible Daily Exposures in manufacturing & human exposure
  • Literature reviews and safety assessment of impurities
  • including extractables & leachables, and genotoxics

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