Additional Information requests,
decoded and answered.
An FDA AI request is the highest-anxiety moment in the submission process. Complizen reads the letter, structures your response plan, assigns every outstanding item, and drafts replies with citations — so you can respond confidently, completely, and on time.
Whatever FDA sends, Complizen helps you respond.
FDA AI requests — the clock is ticking
30-day response window. Multiple technical items. Complizen reads the letter, assigns each item, drafts response language, and tracks outstanding tasks until your submission is complete.
RTA issues — before or after submission
If your submission gets RTAd, Complizen reads the RTA checklist, identifies every deficiency, and generates a correction plan with the exact changes needed to pass RTA on resubmission.
Deficiency letters from CDRH reviewers
Section-specific feedback from your reviewer. Complizen parses each deficiency, drafts a point-by-point response with citations, and flags which sections of your eSTAR need to be updated.
Incorporating Pre-Sub feedback
After your Q-Sub meeting, upload FDA's written response. Complizen updates your submission plan, testing strategy, and open questions — so you enter the formal review cycle with FDA already aligned.
From letter received to response submitted.
Upload the FDA letter
Paste or upload the correspondence. Complizen reads and parses every item.
Review the structured response plan
Each item gets an action plan, suggested sources, and a draft response paragraph.
Refine in Drafting Studio
Edit the response language, add test data, and finalize citations in the editor.
Export and submit
Your complete response package, formatted for the FDA portal. Or send for expert review first.
“When an AI request lands on a Friday afternoon, having Complizen draft the response plan over the weekend changes everything. What used to be a 30-day scramble is now days, not weeks.”
