Regulatory submissions
The module draft, checked against every source.
An operator drafts the section from your study reports, in your own template. Each value carries its source and is checked against your other documents; your regulatory lead signs off.
- ISO 27001
- GDPR
- Every run auditable
Module 2.6.6 Toxicology Written Summary · 2.6.6.3 Repeat-dose toxicity
Calder IND template v3 (.docx)
In the 28-day oral study in rats, CLD-207 was given once daily at 15, 50 and 150 mg/kg/day.
The no-observed-adverse-effect level (NOAEL) was 50 mg/kg/day; at 150 mg/kg/day, ALT rose up to 2.4-fold and returned to baseline by the end of the 14-day recovery period.
In the 28-day study in dogs, the NOAEL was 20 mg/kg/day, the highest dose tested.
Waiting for the regulatory lead's yes before anything uploads.
Upload the Module 2.6.6 draft to SharePoint › IND CLD-207 › Module 2R. Lindqvist, regulatory affairs lead
Illustrative draft: a fictional compound, studies and values that show the output's shape.
Enterprises running operators on Alomana
- up to 94%faster regulatory documents
- up to 50%less first-draft effort
- up to 80%less rework before submission
- Weeks to daysper review cycle
What the operator does with one module
The sources
Reads reports, IB, CMC records, scans
The template
Writes into your Word template
The draft
Drafts sections and summary tables
The trace
Notes the source of every value
The cross-check
Checks values across documents, in code
Agency questions
Drafts answers to agency questions
How the operator drafts a module section
Connect
SharePoint or Drive, plus a folder of templates, SOPs and prior submissions.
Draft and check
Your template, every value sourced and checked across documents.
Sign off
Your regulatory lead edits and approves. Then it uploads and logs it.
FDA information request · Q3
Justify the selection of 150 mg/kg/day as the high dose in Study TX-0412.
Illustrative response
The high dose was selected from the 7-day dose-range-finding study TX-0398, in which 300 mg/kg/day caused body-weight loss of more than 10%. TX-0398 Table 4
150 mg/kg/day was expected to produce identifiable toxicity without exceeding the maximum tolerated dose, as stated in the study plan. TX-0412 §4.1
Drafted for R. Lindqvist to edit and sign
Drafts for your regulatory team, never filings.
The operator stops at a reviewed draft. Publishing and submission stay with your team.
- Sources
- Draft
- Cross-check
- Sign-off
- Publishing and submissionYour team
Nothing leaves the team without a yes.
- Uploads and messages wait for a person's yes
- A declined action is not retried
- Every run logged: input, output, tools, user
- Measured on
- Writer hours per section
- QC corrections
- Inconsistencies found
- Review rounds
- Works with
- SharePoint
- Google Drive
- Confluence
- Jira
- Slack
- Template and SOP folder
- FDA, EMA, ICH guidance
- Your RIM or DMS via MCP
- Built-in operators
- Regulatory Affairs operator
- Clinical Trial Analyst
- Drug Safety Monitor
- Trusted for
- ISO 27001
- GDPR
- Never trains on your data
- Single-tenant for enterprise
A custom operator typically goes live in up to 4 weeks.
Questions regulatory teams ask
What is a regulatory submission operator?
An autonomous agent that drafts sections of submission documents from your own sources. It reads your study reports, IB and prior modules, writes the section into your template, notes the source of every value, and checks each value against its source and your other documents before your team reviews it.
Does it publish or submit anything?
No. It drafts for your regulatory team and stops there. Uploading a draft to SharePoint or Google Drive waits for a person's yes. eCTD assembly, publishing and submission stay with your team and your tools.
Which documents can it draft?
Module sections such as nonclinical and quality summaries and written summaries, plus answers to health authority questions, working from your study reports, IB, CMC records and prior submissions, in your own Word template.
How does it catch inconsistencies?
Every value shows the report, table or page it came from. The operator compares each value with its source and with the same value in your other documents, in code, and lists every disagreement. Your team decides which document is right.
Does it connect to Veeva Vault or our RIM?
Not natively. It reads files from SharePoint, Google Drive or a knowledge folder you give it. A RIM or document management system connects through a remote MCP server for your deployment.
Is our study data private?
Alomana is ISO 27001 certified and GDPR-compliant, and your data is never used to train AI models. Enterprise deployments run single-tenant, in a dedicated instance, and every run is logged with input, output, tools and user.
Bring one module you wrote last quarter.
Talk it over with sales: what the operator needs from your systems, and how it goes live.
Alomana is a secure enterprise AI platform where autonomous agents, called operators, run business processes end to end. Every run is fully auditable.