BlueReg Group

Built on expertise, flexibility and customer orientation, BlueReg provides end-to-end drug development project plans from initial development through authorization and beyond, with full CMC management covering API selection, product development, clinical supplies, registration and geographic rollout. The company's experts support interactions with regulatory agencies, orphan drug designations and pediatric investigation plans, scientific writing for all CTD modules, and pharmacovigilance and post-approval activities, offering in-country services across EU member states including local regulatory affairs, pharmacovigilance, quality management and legal representation for non-EU clients.