bioaccess® runs first-in-human device trials in El Salvador under the Superintendencia de Regulación Sanitaria (SRS) — the autonomous regulator since August 2024 — with centralized ethics at CNEIS and a realistic 3–5 month submission-to-first-patient envelope. No inflated clocks on this page.
bioaccess® is the First-in-Human CRO for El Salvador: Miami headquarters, in-country operations, and the SRS file. The Superintendencia de Regulación Sanitaria (SRS) became the autonomous national regulatory authority in August 2024 under Decreto 891, succeeding the Dirección Nacional de Medicamentos (DNM). Its clinical-trials unit (Unidad de Ensayos Clínicos) reviews the regulatory file while ethics runs centrally at the Comité Nacional de Ética de la Investigación en Salud (CNEIS) — the two submissions run in parallel.