PILLARS
Gestión en Regulación Sanitaria (SG-RS)
SG-RS
Nuestros clientes tendrán las herramientas para estructurar y poner en marcha un área de Asuntos Regulatorios Sanitarios, estandarizando los procesos y actividades que den cumplimiento a la normatividad.
¿Qué es SG-RS?
Con el Sistema de Gestión y Cumplimiento en Regulación Sanitaria SG-RS se otorgan las herramientas, políticas y procedimientos adecuados y suficientes para garantizar, con los recursos existentes, el cumplimiento, observancia y gestión de la regulación sanitaria en las empresas cuyos productos, servicios o procesos están sujetos a control y vigilancia por parte de las autoridades sanitarias de Colombia: INVIMA e ICA.
What does it include?
- Identify the risks the company faces regarding compliance with health regulations.
- Inventory and audit the company's health registrations, establishing continuous control procedures.
- Develop a monitoring and risk detection unit, and manage the health-related controls implemented.
- Resolve and manage non-compliance incidents.
- Create instruments for the ongoing advice of managers and employees on compliance with health regulations.
- Achieve the development of a compliance policy in health regulation and risk mitigation.
¿How do we do it?
Frequently Asked Questions
Health Regulation and INVIMA
Health registrations in Colombia are authorizations issued by INVIMA certifying that a product meets safety, quality, and efficacy standards to be marketed. They are mandatory for medicines, cosmetics, processed foods, medical devices, hygiene and cleaning products, dietary supplements, and household pesticides, among others.
GMP are quality standards that must be met by facilities that manufacture, store, or distribute products regulated by INVIMA. They ensure that products are produced consistently and safely. Non-compliance may result in sanctions, closure of the facility, or cancellation of health registrations.
A health regulation compliance system (HR-MS) establishes internal protocols for monitoring, traceability, and document management that ensure continuous compliance with INVIMA regulations. It includes monitoring the validity of health registrations, preparation for GMP audits, management of adverse event reports, and regulatory updates.
