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Therapeutic Areas

Cardiovascular Disease and Thrombosis

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
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