CORE SERVICES
Regulatory Affairs
Regulatory Affairs
Our in-house Regulatory team is composed of some of Latin America’s leading regulatory experts, giving us an in-depth understanding of the region’s regulatory landscapes. This expertise allows us to stay updated on changes and navigate complex regulations effectively.
Our mission is to integrate regulatory knowledge with strategic commercial planning to create a comprehensive market entry strategy. By bridging the gap between Regulatory Affairs and Business Development, we help clients launch products successfully, minimizing risks and optimizing timelines for market success.
Regulatory strategy
Whether you aim to access a particular country, or aim to take a more regional approach, we can help to plan strategies and ensure that your entry to the region is as smooth and cost effective as possible.
Market Labeling:
Our labelling services are tailored to ensure that products meet all regulatory requirements for market entry and compliance. We focus on accurate, clear, and compliant labelling that aligns with local and international standards.
QMS:
Our QMS services ensure compliance and improve efficiency through system development, internal audits, and staff training. We help design a Quality Management System that aligns with industry regulations and standards. Our internal audits assess existing processes, identify gaps, and recommend corrective actions.
Compliance:
We offer a full suite of compliance services designed to meet regulatory standards and enhance operational integrity. Through detailed context analysis, policy development, and targeted work, we ensure a robust compliance framework is in place. Our services also include staff awareness and training programs.
We specialize in
- Medical Devices and IVDs
- Cosmetics
- Medications
- Food and Dietary Supplements
- Household Sanitizers