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(511) 711 - 9070

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Evaluation of Safety and Efficacy Documents for the Sanitary Registration of Medicines in Bolivia

Evaluation of Safety and Efficacy Documents for the Sanitary Registration of Medicines in Bolivia

Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The process of evaluation and granting of the Sanitary Registration of Medicines in Bolivia is responsibility of the “Agencia Estatal de Medicamentos y Tecnología en Salud” of the Ministry of Health and Sports, through the Department of Marketing Authorization, specifically through […]

Regulatory Aspects about Verification and Validation in Medical Devices Design

Regulatory Aspects about Verification and Validation in Medical Devices Design

Q.F. Walther Ricardo Vicente MallmaQA Specialist & Regulatory Affairs Coordinator – Medical DevicesSCR Consulting Peru In Peru, medical devices are regulated by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). DIGEMID, as a line organ of the Ministry of Health, supervises all aspects related to the approval, denial, modification of the sanitary registration of […]