How should a MedTech or biotech company approach Latin America market entry?

Sequence it: anchor on US regulatory strategy first, use Latin America for fast, lower-cost first-in-human and early-feasibility data, then stage market access (device registration plus reimbursement) country by country. bioaccess® runs the clinical and regulatory execution end to end.

From the Global Trial Accelerators™ podcast with Carolina Alarco (Bio Strategy Advisors): watch the episode.

How to sequence Latin America market entry

• Anchor on US regulatory strategy first (FDA Pre-Sub, IND/IDE)
• Generate FIH / early-feasibility data in LATAM — 40% faster, ~30% lower cost
• Stage device registration country by country (INVIMA, COFEPRIS, ANVISA…)
• Layer in reimbursement / HTA where commercialization is the goal
• Use an importer-of-record and in-country regulatory support to de-risk logistics

Market access services · US-anchored execution