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Semler Research Center (India)

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Sobre la Empresa

  • Nombre legal: Semler Research Center (India)
  • Nombre internacional: Semler Research Centre Private Limited
  • Marca / Nombre comercial: Semler Research
  • País de registro: India
  • Dirección: Bengaluru, Karnataka, India • Karnataka
  • Año de fundación: 2006
Descripción:

Indian contract research organisation in Bengaluru, Karnataka, with clinical and bioanalytical sites in the city, which ran bioavailability and bioequivalence studies for pharmaceutical companies in support of marketing applications in the United States, Europe and elsewhere. A United States Food and Drug Administration inspection of its bioanalytical facility in late 2015 found substitution and manipulation of study subject samples, and in 2016 the agency told sponsors that its clinical and bioanalytical data were not acceptable while the European Medicines Agency reviewed and recommended suspension of medicines approved on its studies; the company later sued the agency.

Actividades Comerciales

Servicios de Laboratorio y Análisis

Laboratorio de Pruebas

Servicios de Organizaciones de Investigación por Contrato (CRO)

Organización de Investigación Clínica (CRO)

Servicios Regulatorios e Inteligencia de Mercado

Consultor Regulatorio
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