Expand into Latin America faster without regulatory complexity

One regional strategy. One regulatory partner. Faster access to multiple LATAM markets through optimized regulatory pathways.

Trusted by companies expanding across :

🇧🇷 Brazil – 🇲🇽 Mexico – 🇨🇴 Colombia – 🇵🇪 Peru

THE LATAM EXPANSION CHALLENGE

WHY MOST COMPANIES STRUGGLE WITH LATAM MARKET ENTRY

Expanding into Latin America should accelerate your growth, not become a regulatory maze that consumes your resources and delays your competitive advantage.

Country-by-country chaos

Each market demands its own regulatory approach, creating fragmented strategies that slow your expansion timeline.

Too many local consultants

Managing multiple vendors across countries creates communication gaps, inconsistant quality, and coordination nightmares.

Duplicate work & rework

Without a regional strategy, you’re paying for the same documentation and submission multiples times.

Unpredictable timelines

When every market is treated separately, regulatory delays cascade and market entry becomes a guessing game.

There’s a better way to approach LATAM Expansion

THE MANDALA INTERNATIONAL APPROACH

A REGIONAL STRATEGY FOR LATIN AMERICA MARKET ACCESS

Instead of treating each country as an isolated challenge, Mandala International’s regulatory intelligence approach identifies synergies across LATAM markets, accelerating your time-to-market while reducing costs and complexity.

DISCOVER OUR PACK

THE LATAM EXPANSION PACK

Choose the expansion scope that matches your growth ambitions and take advantage of our discounts.

Focused market access for your first LATAM country with complete launch readiness.

Two-country LATAM expansion leveraging a shared regulatory strategy and documentation synergies. *30% discount on Mandala registration fees when signing for two countries simultaneously.

Full regional access across three markets using optimized pathways, equivalencies and fast-track strategies. *Mandala registration fees offered free of charge when registering 3 countries together.

4+ country LATAM expansion : Talored-made offer

WHY PARTNER WITH MANDALA INTERNATIONAL

Your expansion in Latin America deserves a partner with the expertise, relationships and regional perspective to deliver results.

Proven LATAM expertise

Decades of combined expérience navigating Latin America regulatory lansdcapes across multiple health industries.

Direct authority relationships

Established working relationships with ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru) and other key partners.

Multi-industry experience

Deep expertise across medical devices, pharmaceuticals, cosmetics, supplements and veterinary products.

Regional vision

We think LATAM-first, not country-by-country, maximazing synergies and minimazing duplications and reworks.

GET IN TOUCH

LET'S DESIGN YOUR LATAM ROADMAP

Our experts will analyse your product and target markets to create a tailored strategy.

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