Named regulatory delivery lead
Owns the workplan, coordination, issue management, reporting, and delivery path for the defined work package.
Built for lean teams facing international regulatory workload.
Durability Labs is a focused ex-US regulatory-support agency for emerging US drug companies. We assemble the delivery and review team around the jurisdiction and workstream, then manage the work through controlled, source-traceable operations.
A team model—not an individual expert presented as universal coverage.
Regulatory work changes by product, stage, jurisdiction, and deliverable. Each proposal identifies the people and regulated roles required for that specific scope before the engagement begins.
Workstream specialist review
Provide the product-, function-, or jurisdiction-specific interpretation and review the deliverables their roles require.
Qualified local partners as required
Handle separately scoped representation, filing, authority attendance, visits, inspections, testing, or other in-country activities.
What being AI-native means here.
It means designing the operation around controlled retrieval, comparison, drafting, document checks, and workflow speed. It does not mean delegating regulatory judgment to an autonomous system.
Faster preparation
Approved tools can reduce repetitive source, comparison, formatting, and quality-control effort.
Visible sources
The process keeps source provenance and verification connected to the work product.
Controlled review
Drafting, interpretation, regulated review, and client approval remain distinct stages with named owners.
Clear boundaries
Permitted systems, confidential information, AI-assisted tasks, and excluded decisions are agreed in writing.
Who we are building for.
- US-based emerging biotech and pharmaceutical companies
- Regulatory teams without deep international capacity in-house
- Executives and international business-development leaders preparing ex-US decisions
- Human therapeutics: small molecules, biologics, and advanced therapies
What we are not positioning as
- A general AI automation agency across multiple industries
- A generic staffing marketplace or anonymous offshore bench
- An on-ground laboratory, inspection, or local-representation firm
- A substitute for the client's accountable regulatory, medical, quality, safety, or legal roles
Tell us where the internal team needs leverage.
Start with the asset, jurisdiction question, trigger, and workstream. We will determine whether the work can be managed remotely, which specialists it needs, and where a local partner must be separately scoped.