“FDA asks. QueryIQ finds the answer and drafts the response.”

When FDA issues an Information Request, a Complete Response Letter query, or EMA issues a List of Questions, QueryIQ searches your entire submission package, clinical study databases, and prior regulatory correspondence to locate the relevant data — then drafts a structured, citation-backed response in the authority's required format. Your regulatory affairs team reviews and approves a complete draft rather than spending weeks locating source documents from scratch.

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Agent Details

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IndustryPharma · Life Sciences

Output typeRegulatory response drafts

Data isolation✓ 6 layers

Audit trail✓ Immutable

This agent produces finished work ready for your team’s review and approval. It completes entire workflows — not just suggestions or partial answers.

Features

What QueryIQ does.

🔍

Cross-submission data retrieval

Searches your entire submission package — Module 1 through Module 5 documents, clinical study reports, manufacturing records, prior correspondence, and amendment history — to locate the specific data points that answer each individual question in an FDA or EMA query.

✍️

Compliant response document drafting

Drafts formal regulatory responses in FDA's Information Request response format, EMA's List of Questions response format, and Complete Response Letter response format — with the regulatory citation structure, document cross-references, and section organisation that agency reviewers expect.

📎

Citation and cross-reference linking

Every statement in a QueryIQ response is linked to the specific page, section, table, and document it came from — giving your regulatory team instant verification capability and giving the FDA or EMA reviewer a navigable, fully-referenced evidence package.

📊

Response tracking and deadline management

Tracks all open queries, their regulatory deadlines, response status, internal approval workflow stage, and correspondence history — ensuring your team never misses a response window and maintaining a complete searchable record of every regulatory interaction.

Advantages

Why it matters to your team.

The real operational benefits your team will experience — described in terms of the work you will no longer have to do, and the outcomes you will achieve instead.

Weeks of response preparation time recovered per query

Regulatory affairs teams typically spend two to four weeks locating source documents and drafting responses to FDA information requests. QueryIQ delivers a citation-complete response draft in hours — giving your team time to review and refine rather than build from zero.

Fewer follow-up questions from regulators

Well-cited, precisely-referenced responses that directly answer each question reduce the frequency of follow-up questions from FDA and EMA reviewers — shortening the overall review cycle and reducing the total volume of regulatory correspondence your team must manage.

Complete regulatory correspondence record maintained

QueryIQ maintains a full searchable record of every query received, every response sent, every document referenced, and every deadline met — creating the correspondence audit trail that supports inspection readiness across your portfolio.

Multi-authority query management from one workflow

QueryIQ handles queries from FDA, EMA, CDSCO, PMDA, and Health Canada simultaneously — applying the correct response format and regulatory framework for each authority without requiring your team to manually adapt content for each jurisdiction.