Categories
Regulatory Strategy & Filings
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Response Time2 Hours
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Delivery Time5 Weeks
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Location
Service Description
Lumanity builds regulatory strategies tailored to your product, indication, and development
stage. Their experts understand regulatory nuances across multiple jurisdictions including
the U.S. Food & Drug Administration (FDA), and the European Medicines Agency (EMA),
among other agencies, ensuring your development program is prepared in compliance with
the appropriate regulations.
What This Service Includes
Regulatory roadmap development
Assessment of accelerated pathways (Fast Track, Breakthrough, PRIME, etc.)
IND/CTA readiness planning
Early engagement strategy with health authorities
Coordination across clinical, CMC, and nonclinical functions
Frequently Asked Questions
Does Lumanity advise on accelerated approval routes?
Yes — we assess eligibility and prepare justification packages.
What if my program only targets one region?
Lumanity can tailor to FDA-only or EMA-only strategies as needed.
Can Lumanity support orphan drug designation planning?
Absolutely, including eligibility assessment and submission preparation.
How early should global strategy development begin?
Ideally before IND/CTA submission, but it can start at any stage.
