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Therapeutic Areas

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
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40+

Products

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130+

Projects

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