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
  • Impurity assessment and qualification
  • Literature-based safety reviews and risk assessments

 

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