Drug Development Strategies and Guidance for Non-Clinical Toxicology Studies
Design and Analysis of Preclinical Studies
Inhalation Toxicology
Preparation of Quality Submissions including IND/NDA, CTD, CTX/ MAA, and Expert Reports
Review of License Candidates
Evaluation of Unexpected Scientific and Regulatory Issues.
Clinical Investigator Brochures
Preparation of Regulatory Documents for Submission
Product/Project Management
Toxicology and Product Safety Assessment
Protocol Design (GLP and Non-GLP)
Preclinical Study Placement and Monitoring
Report Review and Preparation
Study Summary Tables
Preparation of Toxicology Submissions (IND, CTD, NDA) for FDA and International Agencies
Literature Reviews and White Papers
Experience
Each client’s project is evaluated and managed individually, with the benefit of more than 28 years experience in drug development, including more than 20 years with major pharmaceutical companies. Experience includes the drug development of over 200 compounds, project management for more than 50 drug candidates, completion of more than 60 regulatory submissions, and editing of more than 500 toxicology reports.
