Indications include
- Peripheral artery disease/Critical Limb Ischemia and Buerger’s disease
- Acute and chronic heart failure
- Hypertension/Hypotension
- Myocardial infarction
- Diabetes (all types)
- Hypercholesterolemia
- Obesity and metabolic disorders
- Embolism and thrombosis
- Phenylketonuria
- Arrhythmias, bradychardia, tachychardia
Recent assignments
- Provide regulatory support for obtaining SME status in Europe, and confirm eligibility and for orphan designation
- Provide CMC regulatory assistance for comparability of a cell-based medicinal product
- Assist with drug safety activities for a Phase II clinical trial in Europe
- Prepare, submit and maintain CTA for a drug against hypertension
- Provide pre-market PV Service for a Phase I CT in France
Products
Projects