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
Experience