Our client is the proprietary owner of a haemophilia drug portfolio, clinical programs which is seeking to change the lives of haemophiliacs, across the World. Client is a US-based, SME Biotech and have engaged with the European Medicines Agency (EMA) and EU national authorities through Scientific Advice. Several EU designations have also been sought and approved. At the time, services from their current EU providers were considered disjointed and ‘operational’.