Venezuela has one of the most intricate regulatory environments in Latin America. Human health products are overseen by the Servicio Autónomo de Contraloría Sanitaria (SACS), while veterinary and agricultural products fall under the jurisdiction of the Instituto Nacional de Salud Agrícola Integral (INSAI).
From strict import controls to shifting submission requirements and regulatory timelines, companies must be prepared for rapid changes. Rebexa provides the local insight, operational agility, and regulatory expertise needed to stay compliant and move your products forward without unnecessary setbacks.
Navigate Venezuela’s Regulatory Hurdles with Confidence
Rebexa helps healthcare companies manage complex SACS and INSAI regulations,as well as currency controls,to register and maintain products in the Venezuelan market.
Comprehensive Regulatory Solutions for Human and Animal Health Products.
What We Handle
- Labeling and packaging compliance
- Lifecycle services including renewals and manufacturer changes
- Product registration strategy and classification
- Dossier submission to SACS and INSAI
- Legalization, translation, and apostille of documents
We Support
- Pharmaceuticals (Rx/OTC)
- Controlled substances
- Medical devices and diagnostics
- Veterinary pharmaceuticals
- Personal care and hygiene products
Why Choose Rebexa
- Regulatory expertise in high-risk environments
- Real-time tracking of shifting ministry protocols
- Experience managing document legalization and consular approvals
- Local associates and translators to reduce delays
Venezuela’s Regulatory System is Complicated,But You’re Not Alone.
Partner with Rebexa to streamline your registration and stay compliant.
