Hematology

Indications include

• Hemoglobinopathies: Sickle Cell, Thalassemia
• Anemia (all)
• Haemophilia A or B
• Platelet disorders:  Immune thrombocytopenia, Thrombocytopenia

Recent assignments

• Prepare and submit an ODD in the US and represent the company as US agent
• Perform gap analysis of available data for MAA, recommendations and action plan for filing in identified gaps
• Comparative positioning of an orphan drug on the US market
• Develop a clinical trial application for a drug indicated in haemophilia
• Pre-market pharmacovigilance services in the EU for clinical trials in multiple indications
• Provide strategic advice for European market access