Experience

Therapetic Areas:
                                      Women's health (oral contraceptives, intrauterine systems)
                                      Diagnostic imaging (gadolinium- and iodine contrast agents)
                                      Molecular imaging
                                      Cardiovascular (antiarrhythmics, kinases, coagulation)
                                      Radiopharmaceuticals (for imaging and oncology)
                                      Dermatology
                                      Oncology
Regulatory Submissions:
                                      INDs (standard and exploratory)
                                      NDAs [standard, supplemental, 501(b)(2) applications]
                                      Information amendments and annual reports to FDA
                                      Briefing packages (FDA and EMA)
                                      Orphan drug and fast track designation requests
                                      Special protocol submissions (carcinogenicity and pediatric)
                                      Product labeling, corporate core text, MSDS
Regulatory Meetings:
                                     pre-IND, end-of-Phase 2, pre-NDA, NDA orientation, ad-hoc
                                     EMA Scientific Advice
                                     FDA public advisory committee
Nonclinical studies:
                                     Safety pharmacology studies Systemic toxicology studies
                                     Carcinogenicity studies
                                     Reproduction toxicology studies
                                     Genetic toxicolgy studies
                                     Phototoxicity and photo co-carcinogenicity
                                     Local tolerance studies

Triskelion Toxicology LLC