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QSCL has extensive experience in preparing review documents for use by Client Development Teams project teams, as well as documents for regulatory submission. QSCL has well established and tested QC procedures and complies with copyright law.

Nonclinical reviews

  • Nonclinical reviews for cause
    • licensing diligence, impurities including extractables & leachables, genotoxics, PDEs for cleaning validation, change of supplier

Briefing documents

  • Briefing documents for meetings at FDA, MHRA and other EU agencies

Documents for regulatory approval

  • Investigator’s Brochures
  • Common Technical Documents (CTD) §2.4 & 2.6
    • for applications for EU Market Approval, Investigational New Drugs & New Drug Applications

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