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