Preclinical Pharmaceutical Development Drug Development Strategies and Guidance for Non-Clinical Toxicology Studies Design and Analysis of Preclinical StudiesInhalation 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 26 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.
