Nonclinical Consulting

Intrinsik is recognized internationally as a leader in providing expert scientific opinions, nonclinical development strategies, and nonclinical documents for regulatory submissions.  Our scientific experts include board certified toxicologists to provide expert assessments and advice.

Services:

• • Nonclinical regulatory strategy including bridging toxicology programs for repurposed molecules – e.g. 505(b)(2)
  • Management of development programs
  • CRO selection and study placement
  • Toxicology consulting and strategic advice
  • Study monitoring, including GLP auditing
  • Study design, review of protocols and reports
  • Authoring of CTD Modules 2.4 and 2.6
  • Literature-based safety reviews and risk assessments
  • Impurity assessment and qualification
    • Evaluation of impurities in the API and/or drug product consistent with ICH recommended approaches for initial assessment of impurities (M7 2015), using Leadscope FDA Model Applier  2. 0, an FDA-validated QSAR software program that includes both expert rule- and statistical-based models.
    • Identification of structural alerts in pharmaceutical compounds and impurities using QSAR.
    • Evaluation of excipients that exceed FDA inactive ingredient levels and development of higher safe levels acceptable to the agency.
    • Evaluation of extractable/leachable impurities and justification for the safety of extractables in the API and drug product.