PILLARS
Health Regulation Management System (SG-RS)
SG-RS
Our clients gain the tools to structure and launch a Health Regulatory Affairs function, standardizing the processes and activities required for regulatory compliance.
What is SG-RS?
The SG-RS Health Regulation Management and Compliance System provides the tools, policies and procedures needed to ensure — using existing resources — compliance with and management of health regulations in companies whose products, services or processes are subject to oversight by Colombia's health authorities: INVIMA and 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.
