Categories
Regulatory Strategy & Filings — Submission Preparation
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Response Time4 Hours
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Delivery Time4 Weeks
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Location
Service Description
Lumanity prepares, authors, and manages regulatory submissions including INDs, NDAs, BLAs, CTAs, and MAAs. Their scientific writers, regulatory strategists, and project managers work together to craft clear, compliant, and compelling submissions designed to withstand rigorous agency review.
What This Service Includes
IND, CTA, NDA/BLA, and MAA submission packages
Authoring and reviewing clinical, nonclinical, and CMC modules
Submission readiness audits
eCTD formatting and publishing
Cross-functional documentation alignment
Frequently Asked Questions
How long does IND preparation typically take?
Timelines vary, but Lumanity can support both standard and accelerated IND builds.
Does Lumanity support eCTD publishing?
Yes — we provide complete eCTD preparation and submission services.
Can they help remediate a submission that has already been started?
Yes, we frequently step in to rescue at-risk submissions.
Do we support post-submission questions from FDA/EMA?
Absolutely — we prepare responses and strategy for all agency inquiries.
