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Regulatory Approach to Stability Studies of Medicines in Bolivia

Scope of Resolution N° 886: “Guide for Medicines Stability Studies in Bolivia”

Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of pharmaceutical products are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Drug Regulation Authority must work together to ensure that […]

Regulatory Approach to Stability Studies of Medicines in Bolivia

Regulatory Approach to Stability Studies of Medicines in Bolivia

Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consulting Bolivia The safety and efficacy of medicines are influenced not only by their intrinsic properties, but also by their stability during the manufacturing process. Based on these premises, manufacturers and the Bolivian Medicines Regulatory Authority must work together to ensure that all […]

Requirements for Food Sanitary Registration in Bolivia

Requirements for Food Sanitary Registration in Bolivia

Q.F. Mary Carmen Chuquimia SocpazaQuality Specialist & Regulatory Affairs CoordinatorSCR Consulting Bolivia Food Safety is the guarantee that food will not cause harm to the consumer when prepared and/or consumed, without posing health risks. This condition involves several actors (primary producers, food processors, transporters, food traders and final consumers) along the food chain up to […]

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 […]