NonClinical Toxicology Consulting, LLC
Pharmaceuticals - Longmont, Colorado, United States
NonClinical Toxicology Consulting, LLC Employees
NonClinical Toxicology Consulting, LLC Details
Toxicology consulting, including:- Propose, design, place, monitor, and report early toxicology studies to identify potential preclinical liabilities early during the lead optimization phase- Provide preclinical development plan for small molecules to enable first in human studies and to support marketing applications- Identify toxicology contract research organizations (CROs) for toxicology studies, develop protocols, monitor study conduct and review reports- Write regulatory agency submission quality reports with data provided from the client's lab or a CRO - Write non-clinical sections of IB (investigator brochure), INDs (investigational new drug application), CTAs (clinical trial application), and marketing applications- Write risk assessment and identify first in human doses- Represent client at regulatory agency meetings and respond to any non-clinical regulatory issues - Provide team leadership and project management for the nonclinical aspects of drug development programs- Perform due diligence for potential inlicensed compounds- Identify and convene scientific experts, and other drug development consultans, when needed
