An allograft is human tissue donated by one person for implantation into another genetically distinct individual. Its processing is carried out by tissue banks or biotechnology companies in strict compliance with procedures designed to ensure its quality, safety, preservation, and traceability prior to implantation into another person through a surgical procedure. Due to its unique […]
When a medical device is not subject to mandatory health registration in Chile, the ISP Background Review may serve as a technical and commercial support tool. Learn when it applies, what its scope is, and how to integrate it into a market-entry strategy.
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs and Pharmacovigilance Analyst SCR Consulting Peru As part of the development of the pharmacovigilance system in Peru, since the publication of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products (Supreme Decree No. 016-2011-SA), the preparation and presentation of the […]
Q.F. Luz Marianee Castañeda Saavedra Quality and Regulatory Affairs Specialist SCR Consulting Peru BACKGROUND OF THE REGULATION OF THE SANITARY REGISTRATION OF PHARMACEUTICAL PRODUCTS In the late 1990s, with the enactment of General Health Law No. 26842 in Peru, it was established that the registration of medicines in the Sanitary Registry was automatic, requiring only […]
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs, Safety and Efficacy Analyst SCR Consulting Peru With the enactment of the Law No. 29459: “Law on Pharmaceutical Products, Medical Devices and Health Products” in 2009; and subsequently with the approval of the “Regulations for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health […]
In the complex and rigorous world of the pharmaceutical, cosmetic and medical device industries, regulatory affairs management plays a crucial role in ensuring that companies not only comply with current regulations, but also protect the welfare of public health. In this context, the professionals in charge of regulatory affairs, with their deep knowledge and experience, […]
Q.F. Idaly Jazminy Morote Guzmán QA Specialist & Biologics and Drug Regulatory Affairs Coordinator SCR Consulting Peru Q.F. Mary Carmen Chuquimia Socpaza Quality Specialist & Regulatory Affairs Coordinator SCR Consultores Bolivia The Pan American Network for Drug Regulatory Harmonization (PANDRH), made up of the Drug Regulatory Authorities of 35 Member States and representatives of the […]
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 […]
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 […]