Product context
Modality, stage, indication, development status, and the decision or trigger driving the assessment.
Decide what ex-US expansion will require before execution begins.
The Ex-US Regulatory Expansion Readiness Sprint is a bounded decision engagement for emerging drug companies comparing markets, preparing partner discussions, or determining whether a US package is reusable internationally.
A decision package—not a generic market report.
The sprint organizes the regulatory question around the product, target-market assumptions, available evidence, dossier, local requirements, responsibilities, and execution dependencies.
- Decision framing and documented target-market assumptions
- Pathway and regulatory-responsibility map
- High-level dossier readiness and localization gap register
- Authority-interaction, labeling, lifecycle, and local-party requirements
- Prioritized workplan, dependencies, specialist needs, and budget ranges
- Executive readout with the decisions and go/no-go questions still open
What the sprint needs from your team.
The scope is designed to minimize disruption while making assumptions explicit. Confidential material is requested only after permitted systems, access, retention, and AI-use rules are agreed.
Regulatory history
US regulatory status, material authority decisions, prior questions, and other facts relevant to the target-market assumptions.
Document inventory
Available modules or sections at the agreed level, along with known gaps, owners, and current versions.
Client decisions
Named contributors and approvers who can validate assumptions, resolve open questions, and own final regulatory and commercial decisions.
What happens after readiness is clear.
The sprint ends with a workplan rather than an automatic retainer. Your team can execute internally, engage Durability Labs for defined work packages, or use qualified local providers where the plan requires them.
Execute through your internal team
Use the gap register, responsibility map, and workplan to sequence work through the existing team.
Outsource defined packages
Convert prioritized dossier, localization, submission, labeling, or lifecycle work into separately scoped managed outcomes.
Coordinate qualified local partners
Identify and coordinate qualified in-country providers for representation, filing, visits, or other local activities when needed.
Start with the decision your team needs to make.
Bring the asset, current US status, markets under consideration, and the trigger. We will confirm whether a readiness sprint is the right first engagement and define its scope before any confidential material is shared.