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.


    • 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.

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us