Connecting pharmaceutical innovation with
Latin American markets

We are the strategic partner for international laboratories seeking to register, structure, and scale their products across Latin American markets with regulatory rigor, commercial insight, and reliable execution.

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Expanding into Latin America is complex, highly regulated, and deeply competitive

- Local regulatory barriers (ISP, COFEPRIS, ANVISA, INVIMA)
- Limited understanding of real market dynamics
- Risk of registering products with low commercial potential
- Cultural and language barriers
- Fragmented distribution networks
- Lack of transparency in processes
Registering a product is not enough.
A comprehensive market access and commercial execution strategy is required.
Molek Pharma was founded with the vision of becoming the strategic partner of choice for international laboratories seeking sustainable expansion across Latin America.

Our team brings together over 20 years of experience in business development, international negotiations, regulatory compliance, and pharmaceutical strategy.

We operate under international standards, prioritizing ethics, transparency, technical rigor, and long-term commercial sustainability.

International Structure. Strategic Mindset. Local Execution.

Regulatory Strategy & Market Access

01

WHAT WE DO

  • Pre-registration commercial feasibility analysis
  • Competitive assessment and market positioning
  • Regulatory registration management
  • Dossier coordination and regulatory compliance
  • End-to-end support through approval

Strategic Representation & International Negotiation

02
  • Regional representation before manufacturers
  • Structuring of licensing agreements and commercial deals
  • Negotiation of strategic terms and conditions
  • Regional volume consolidation


Commercial Execution & Distribution

03
  • Established network of distributors across Latin America
  • Vertical integration when strategically required
  • Demand forecasting and supply planning
  • Purchase order management
  • Post-registration execution and follow-up


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✔ Strategic validation before registration
✔ Transparency at every stage of the process
✔ Speed of execution
✔ Regional volume consolidation
✔ International mindset with local execution
✔ Structured, compliance-driven negotiations

We are strategic enablers of expansion for the pharmaceutical industry

WHY Molek?

Commitment to International Standards


We work exclusively with laboratories that comply with GMP certifications and international regulatory standards.

Our approach prioritizes:

Regulatory compliance
Contractual transparency
Information protection (NDA)
Strong legal structuring
Corporate governance

We seek to build long-term partnerships with:

Innovative pharmaceutical laboratories

Manufacturers with international standards

Strategic distributors across Latin America

Companies seeking regional expansion

Aura Febles
CEO
Commercial & Institutional Strategy


Experience at Galenicum
Institutional commercial leadership
End-to-end executive management

ALEJANDRA TIRONI
Business Development
Legal & Strategic Partnerships


10+ years at Abbott
International experience
Swiss governance standards
Strategic negotiation expertise

Leadership Team

A team combining global vision with
regional execution

Héctor de la Roca
Co-Founder
Business Development & Strategic Negotiations


20+ years of experience in the pharmaceutical industry across Latin America
Expertise in licensing, portfolio strategy, and strategic negotiations

OUR PROCESS

Our process follows a structured and collaborative approach, ensuring full visibility at every stage—from initial assessment to product launch.

We maintain continuous communication and leverage tracking tools that guarantee transparency, traceability, and full process control.

1️⃣ Strategic Alignment & Confidentiality

2️⃣ Market Intelligence

3️⃣ Regulatory Feasibility Assessment

4️⃣ Regulatory Dossier Management

5️⃣ Supply Coordination

6️⃣ Importation & Market Authorization Strategy

7️⃣ Market Access Strategy

8️⃣ Public Tender Management

9️⃣ Distribution Channel Optimization


Let’s design your market entry strategy together.

Are you ready to expand your portfolio in Latin America?