Free, no obligation

Get your custom First-in-Human roadmap

Tell us about your asset and target country. We respond within 1 business day, then follow with a detailed FIH plan: regulatory pathway, site selection, indicative timeline, and indicative budget — at no cost to you.

We take on a limited number of new FIH programs each quarter.

What you get

• Regulatory pathway. Country-specific submission strategy (INVIMA, COFEPRIS, ANVISA, ANMAT, ISP, DIGEMID, or U.S. FDA Pre-Sub/IND/IDE) with the exact documents, timelines, and ethics-committee route for your asset.
• Indicative timeline. Week-by-week plan from protocol finalization to last patient last visit, benchmarked against our 12-month FIH delivery guarantee and materially faster than US/EU pathways.
• Indicative budget. Per-patient costs, site fees, regulatory fees, monitoring, insurance, and import/export — itemized so you can take it to your board or investors.

Why bioaccess®

• 50+ clients since 2010
• 12-month FIH delivery guarantee
• Lead Latin American FIH jurisdictions plus U.S. regulatory anchoring
• EN / ES / PT trilingual project teams

Frequently asked questions

How fast will I hear back?

We respond within 1 business day of your submission. Your detailed roadmap follows once we have reviewed your details; we will tell you upfront what to expect for your case.

Is the roadmap really free?

Yes. There is no cost and no obligation. The roadmap is yours to keep whether or not you engage bioaccess® to run the trial.

Which countries can you cover?

Our lead FIH execution jurisdictions (Panama, El Salvador, Chile, and the Dominican Republic), other Latin American countries on request, plus U.S. regulatory anchoring (FDA Pre-Sub, IND, IDE). We recommend the optimal execution country based on your asset, indication, and regulatory goals.

What information do you need from me?

Your asset (device, drug, or biologic), the indication, your target country or "recommend one," your expected patient count, and your preferred timeline window. The form takes about 3 minutes to complete.

What happens after I get the roadmap?

You can act on it independently, share it with your board, or schedule a 30-minute review call with our team — your choice. We will not pressure you to engage bioaccess® for execution.

Request your roadmap · Contact bioaccess®