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Semler Research Center (India)

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À Propos de l'Entreprise

  • Raison sociale: Semler Research Center (India)
  • Nom international: Semler Research Centre Private Limited
  • Marque / Nom commercial: Semler Research
  • Pays d'enregistrement: India
  • Adresse: Bengaluru, Karnataka, India • Karnataka
  • Année de création: 2006
Description:

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.

Activités Commerciales

Services de Laboratoire & d'Analyse

Laboratoire d'Essais

Services d'Organismes de Recherche sous Contrat (CRO)

Organisation de Recherche Clinique (CRO)

Services Réglementaires & d'Intelligence de Marché

Consultant Réglementaire
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