One product.
Many pathways.
Every regulator in the Americas has its own requirements, timelines, and expectations. We help you plan the sequence — and build documentation you can reuse from one agency to the next.
Regulatory Strategy,
end to end.
Pick one piece or the whole program. Every engagement is scoped to your goals, markets, and timeline.
Pathway assessment
Classification and pathway analysis for each target market, from the U.S. Food and Drug Administration (FDA) to Brazil's ANVISA and beyond.
Multi-market sequencing
A filing order that builds on earlier approvals and uses reliance pathways where they exist.
Dossier gap analysis
Your technical documentation reviewed against each market's requirements, with a clear list of what's missing.
Submission support
Preparation and coordination of individual submissions, including translations and local representative needs.
Agency interactions
Preparation for agency meetings and support responding to questions and deficiency letters.
Post-market obligations
Vigilance, complaint handling, renewals, and change notifications planned from day one.
Clear deliverables.
Classification and route for every target market.
What your documentation covers today — and what it doesn't.
Sequence, timeline, owners, and dependencies.
Post-market requirements by country, in one place.
Simple steps.
Serious rigor.
Classify
Determine how your product is classified in each market.
Sequence
Choose a filing order that builds momentum.
Prepare
Close gaps and assemble country-specific submissions.
Maintain
Keep registrations current as products and rules change.
Built for builders.
Engagements can be as focused as a single submission or as broad as a hemisphere-wide regulatory plan.