Expert Guidance for Complex Markets

Navigating the fragmented regulatory landscape of Central America, South America, and the Caribbean requires more than basic know-how-it demands seasoned insight. At Rebexa, our consulting services are rooted in regional experience, regulatory fluency, and a deep understanding of how market dynamics and agency expectations vary by country.

We work closely with your team to uncover the most efficient regulatory path forward whether you're preparing for market entry, product expansion, or managing a complex product portfolio.

• Regulatory landscape analysis
• Market prioritization strategies
• Health authority engagement planning
• Advisory for mergers, acquisitions, and portfolio transfers

Registration Without the Roadblocks

Every product launch or product change begins with registration and in LATAM and the Caribbean, that process can be unpredictable without the right support. Rebexa prepares, submits, and monitors your product applications with precision, ensuring alignment with local standards and reducing the likelihood of setbacks.

Our team brings a track record of successful registrations for a wide range of product types across 16+ countries.

• Country-specific registration planning
• Coordination with Ministries of Health
• Application tracking and status updates
• Fast-track and standard pathway navigation
• Certificate and license retrieval

Local Representation. Regional Reach.

Many countries in Central America, South America, and the Caribbean require local legal or technical presence as a condition for product registration. Rebexa offers in-country representation and license holding through our own legal entities or a network of trusted associates.

We serve as your Marketing Authorization Holder (MAH) when needed, provide local regulatory liaison, and represent your product in audits and inspections ensuring full compliance without the need to establish a physical presence.

• Legal entity support and documentation
• MAH and authorized representative services
• Local regulator communications
• Representation in inspections and audits

From Launch to Long-Term Compliance

Regulatory obligations don’t end after approval. Rebexa helps you manage every step post-launch-from renewals and variations to labeling updates and market withdrawals.

Our lifecycle support ensures your product stays in market, in compliance, and ahead of evolving local regulations.

• License renewals and variation submissions
• Manufacturer or distributor changes
• Label and prescribing information updates
• Notifications of changes to Ministries of Health

Submission-Ready, Market by Market

Strong dossiers lead to smooth approvals. We prepare high-quality, country-specific submissions that meet the exact formatting and documentation standards required by local authorities.

By anticipating common pitfalls and tailoring each submission to the local context, we help avoid unnecessary questions, rejections, and delays.

• CTD, STED, and regional dossier formatting
• Technical content review
• Legal and certified translations
• Submission packaging and delivery
• Follow-up with health authorities

Smart Strategy. Faster Outcomes.

A well-defined regulatory strategy saves time, reduces risk, and positions your product for long-term success. Rebexa works with you to craft market-specific plans that align with your goals, timelines, and resources.

We don’t just react to rules we help you anticipate them.

• Regulatory pathway design
• Country prioritization
• Timeline and cost modeling
• Portfolio planning and sequencing

Stay Ahead of Change

In LATAM and the Caribbean, regulations shift constantly and staying compliant requires proactive monitoring and swift action. Rebexa keeps you informed and aligned with every change that affects your products, registrations, or labeling.

We don’t wait for problems to appear we flag them before they become issues.

• Regulatory intelligence and alerts
• Compliance audits and readiness reviews
• Post-market reporting and safety updates
• Label and packaging revision tracking
• Integration with Reportas™ for real-time monitoring