“First-draft CTD summaries in hours, not weeks.”

MedWrite AI reads your clinical study reports, nonclinical data packages, and existing product quality documents and generates complete Module 2 CTD summaries formatted to FDA and EMA eCTD v4.0 specifications. Your medical writers receive a structured, section-complete first draft built from your own data, ready for scientific review and approval rather than from a blank page.

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Agent Details

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IndustryPharma · Life Sciences

Output typeComplete draft documents

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 MedWrite AI does.

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Module 2 CTD authoring

Generates all Module 2 CTD documents — 2.3 Quality Overall Summary, 2.4 Nonclinical Overview, 2.5 Clinical Overview, and 2.6 and 2.7 Nonclinical and Clinical Summaries — reading directly from your actual study data rather than producing generic placeholder text.

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eCTD v4.0 formatted output

Every generated document is structured to eCTD v4.0 specifications — the correct section hierarchy, ICH heading numbering, cross-reference conventions, and pagination formatting required for FDA and EMA electronic submissions.

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Source document traceability

Every statement in a generated summary is linked to the specific study, page, and section it originated from — giving your medical writers instant traceability for verification and the regulatory reviewer a complete citation chain.

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Iterative section refinement

When your regulatory team requests changes to specific sections, MedWrite AI updates those sections in isolation without regenerating the full document — preserving tracked-change history and prior editorial decisions throughout the review cycle.

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.

Blank pages replaced with structured first drafts

Medical writers no longer start from zero. They receive a structured, data-populated first draft — removing the most time-consuming and error-prone phase of CTD authoring and letting your team focus entirely on scientific review.

Three to six weeks of writing time recovered per submission

Module 2 summaries that previously consumed three to six weeks of senior medical writer time are generated in hours — accelerating your overall submission timeline without adding headcount or external contractors.

Fewer FDA information requests from authoring errors

By generating summaries directly from source study documents, MedWrite AI eliminates the transcription errors and data inconsistencies between source data and summaries that frequently trigger FDA information requests post-submission.

Simultaneous multi-authority formatting

MedWrite AI prepares Module 2 summaries simultaneously formatted for FDA 21 CFR, EMA, and CDSCO requirements — removing the sequential reformatting effort currently required when a single submission must satisfy multiple health authorities.