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.