AI-assisted regulatory operating system
From source data
to a living dossier.
SAGAREG keeps source data, dossier content, market versions and changes in one governed product record, with portfolio and competitor views on top. AI drafts; your team reviews and approves.
For generics, biosimilars and regulatory service teams.
ORGANIZED BY PRODUCT
01Bring your data
- Source files
- Templates
- Earlier dossiers
02Build one product record
One product record
- M1
- M2
- M3
- M4
- M5
Source-linked text & tables
03Adapt and deliver
- Market A
- Market B
- Market C
Shared content · controlled local differences
Product context, not isolated prompts.
Traceability alongside authoring.
AI assistance without AI approval.
WHERE TEAMS SAVE TIME
Less rework.
Faster dossiers.
SAGAREG is designed to reduce repetitive drafting, review and market-by-market rework across the dossier lifecycle.
- 01
Drafting & assembly
Reuse source data, templates and earlier dossiers instead of rebuilding content from scratch.
- 02
Adapting for another market
Keep shared content once and adjust only the local differences for each market version.
- 03
Changes & authority questions
When a question or change arrives, see the affected sections, markets, milestones and competitor context, then review the update without changing earlier submissions.
THE PLATFORM
Evidence, content
and decisions, in one place.
One governed record for every CTD module, from first draft through lifecycle changes. Today the authoring focus is Module 2 and Module 3; next, eCTD v4.0 and deeper biosimilar comparability support.
Start with evidence you can inspect.
Bring source documents and quality information into a product workspace, with source relationships retained for review.
Organize source documents and evidence
Bring PDFs, Word documents and spreadsheets into a product workspace. SAGAREG extracts text and tables, keeps each fact linked to its source and location, and flags anything unreadable or ambiguous.
Inspect quality and stability information
Review specifications, analytical methods, process steps and shelf-life statements drawn from source. Stability workbooks keep cell-level lineage and feed study summaries. Scientific conclusions need a reviewer’s decision.
Draft from approved product evidence.
Your templates. Your style. Quality content and summaries built from the product record.
Assist with Module 3 authoring
Draft quality sections from approved product evidence, your templates and reference material. Deterministic compilers handle structured content; governed AI handles planning and prose. Every draft keeps its evidence links, and gaps stay visible.
Prepare the Quality Overall Summary
Build Module 2.3 from approved Module 3 revisions. Each summary claim links back to the section version it came from.
Reuse approved company experience
Apply your approved narrative patterns, prior dossier structures and past review corrections. Experience guides structure and wording; current-product evidence still backs every claim.
Work with a product assistant
Find records, get cited explanations of dossier content and preview drafting proposals. Proposals go through normal jobs and review; the assistant never approves.
A shared core. Explicit market differences.
Keep market applications tied to the core dossier without pretending every market is identical.
Manage a shared core and market applications
Applications inherit approved core content or hold an explicit local override. SAGAREG records which core revision each override is based on and flags when that baseline moves.
Make review and readiness inspectable
See draft content, source support, validation findings and open requirements together. Review and approval are separate recorded actions, approval requires fresh authentication, and changed content never inherits an earlier approval.
Maintain the dossier as the product evolves.
Keep change assessments, lifecycle records and controlled outputs together without discarding earlier regulatory history.
Coordinate changes and lifecycle records
Run change cases, impact assessments and reviewed change sets, then carry approved content through market propagation, sequences, filing records, authority outcomes and commitments.
Prepare controlled document outputs
Render dossier content and build eCTD v3.2.2 sequence packages with lifecycle information retained. Local checks catch package problems before handoff to your publishing tool.
See the bigger picture.
Portfolio and competitor views drawn from the same governed record as your dossiers, not a separate tracker.
Follow portfolio status
See every product with its markets, next milestones and blockers in one view. Status, dates and blockers come from the same record your team works in.
Compare known competitor activity
Compare your product with known competitor activity, market by market, for the same scope. Each competitor entry links to its evidence, and competitor context appears when a question or change affects a milestone.
Current scopeThese capabilities describe implemented product scope; availability and pilot scope are confirmed per customer. Generated content, readiness findings and exports support your team’s judgement. They are not regulatory approval, a compliance certificate or an authority submission, and external publishing validation is still required.
LET’S TALK
See SAGAREG on your
own dossier work.
In 25 minutes we’ll walk through one product and one or two dossier sections, then help you choose how to start. No preparation needed: we can use SAGAREG-owned or cleared material.
Two ways to start
Team-led evaluation
Your team tests SAGAREG on a bounded example. Platform scope is agreed afterwards.
Managed writing
We write the agreed documents for you with SAGAREG, using a qualified author and reviewer. No software rollout needed to start.