# Regulatory submissions software for post-approval changes and NDA and BLA dossiers
The QLogix regulatory submissions module is regulatory submissions software that documents regulatory affairs' assessment of a change and drafts submission text in which every claim quotes its source. For a post-approval change, the AI screens the change control for regulatory impact: the registered details affected, the supporting data, and a suggested reporting route in each market where the product is registered, which regulatory affairs confirms or changes with a reason. For a new NDA or BLA, the AI checks the documents against an eCTD template, Modules 1 to 5, section by section, and drafts the sections regulatory affairs asks for. A person verifies or rejects each claim before a section can be approved, and the filing itself is made in the organization's regulatory system.
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## What the module does
- Change screening by type of change (manufacturing process or equipment, component, material or supplier, container closure, specification or analytical method, site, labelling, shelf life or storage) for the markets where the product is registered: United States, European Union, United Kingdom, Canada, Japan and others.
- A regulatory impact assessment: what changes, the registered details affected by CTD section with the quote, a supporting-data checklist (provided, incomplete, missing), questions for regulatory affairs, and a classification: prior approval likely, notification likely sufficient, likely no filing, or cannot determine.
- A suggested reporting route per market with the condition that puts the change there: Prior Approval Supplement, CBE-30, CBE-0 or Annual Report in the United States; Type IA, IAIN, IB or II variation in the EU and UK; Level I to IV in Canada; partial change approval or minor change notification in Japan.
- Regulatory affairs' decision for each market, with a reason: suggested route confirmed, a different category, or no filing in this market.
- Submission sections drafted by the AI (description of the change, justification, impact on quality, safety and efficacy, summary of supporting data, comparability, cover letter), each fact marked [C1], [C2] with the exact quote from its source and unsupported points listed as not sourced.
- NDA 505(b)(1), NDA 505(b)(2) and BLA 351(a) applications on an eCTD template, Modules 1 to 5 with the US regional Module 1, each section with its purpose, contents, analytical expectations, regulatory basis and the deficiencies that most often lead to a refuse-to-file or an information request.
- A readiness check of the dossier documents against every template section (ready to draft, partial, missing, not applicable) with the filing risks, and section drafting guided by the template and the regulatory library passages it names.
- Claim-by-claim verification: a section is approved only when every claim is verified, approved sections cannot be edited, and the decision is recorded and signed in review and approval.

## How it fits the platform
A change control's impact assessment says whether regulatory screening is needed, and a change that may need a filing goes to a regulatory impact screening, with the change control record, specifications, qualification and validation reports and stability data attached as its sources. The CMC facts a section states come from documents named in its claims, so the reviewer checks each one against its quote.
Open submission records appear in the work queue with the rest of the quality system, and a prior-approval change without a regulatory affairs decision raises an alert after seven days.

## Where people decide
The AI screens the change, suggests a category with its confidence and drafts the text; regulatory affairs decides each route, verifies or rejects each claim, approves each section and records the decision, which is signed in review and approval. The AI does not state that a filing is or is not required. The filing is made in the organization's regulatory system; the QLogix record documents the assessment, the sources and the decision.

## Where people decide
- The reporting route in each market is decided by regulatory affairs with a reason; the AI's category is a suggestion.
- A section is approved only when every claim in it is verified; an approved section cannot be edited.
- Proceeding to submission needs at least one approved section, and the decision is signed in review and approval.

## Built to
- 21 CFR 314.70 and 601.12 post-approval changes
- 21 CFR 314.50 and 601.2 applications
- ICH M4 Common Technical Document
- Regulation (EC) No 1234/2008 on variations
- Health Canada Post-Notice of Compliance changes guidance
- 21 CFR Part 11 and EU GMP Annex 11

## White paper
From change control to filed dossier
AI-enabled regulatory submissions on an Agentic QMS
[Download the white paper](https://qlogix.ai/whitepapers#regulatory-submissions)

## Licensing
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Every module writes to the same audited records.
[Ask for a quote](https://qlogix.ai/contact)

## Questions about Regulatory submissions

### What is a regulatory impact assessment?

It decides whether a change to an approved product touches registered details in the dossier and, if it does, which reporting category applies in each market. In QLogix the AI lists the registered details affected with quotes, the supporting data provided or missing and a suggested route per market. Regulatory affairs confirms or changes each route with a reason.

### Which post-approval reporting categories does it consider?

Prior Approval Supplement, CBE-30, CBE-0 and Annual Report in the United States; Type IA, IAIN, IB and II variations in the EU and UK; Level I to IV changes in Canada; and partial change approval or minor change notification in Japan. Each suggestion names the condition that puts the change in its category.

### Does it draft NDA and BLA dossiers?

It supports NDA 505(b)(1), NDA 505(b)(2) and BLA 351(a) applications on an eCTD template covering Modules 1 to 5 with the US regional Module 1. The AI checks the documents against every template section, then drafts the sections regulatory affairs chooses, each claim quoting its source. Forms, datasets and study reports are compiled, not drafted.

### Does QLogix file the submission or publish the eCTD?

No. The filing is made in your regulatory system. The QLogix record documents the impact assessment, the sources, the verified sections and regulatory affairs' signed decision.

### How is the AI kept from inventing data in a submission?

Every statement of fact carries a claim marker with the exact quote from the change description or a named document, and points the sources do not support are listed as not sourced instead of written. A person verifies or rejects each claim, and a section cannot be approved until every claim is verified.

### How is it licensed?

Per user per month, on its own or with other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.

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[All 18 product pages](https://qlogix.ai/products)

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Source: https://qlogix.ai/products/regulatory-submissions
QLogix · contact@qlogix.ai · +17146639012