AI-assisted regulatory operating system
Connect your
pharmaceutical
evidence, dossiers and
regulatory work.
SAGAREG brings source documents, quality evidence, dossier authoring and controlled changes into one product workspace, with AI assistance and human review built into the process.
Generic medicines · Biosimilars · Regulatory & CMC teams
CONNECTED BY PRODUCT
From source to dossier.
- Source documentsPDFs · Word documents · Spreadsheets01
- Reviewed evidenceSource identity and location retained02
- Dossier contentModule 3 · Module 2.303
- Human review & approvalDecisions against exact revisions04
- Market applicationsShared core · explicit local overrides05
Product context, not isolated prompts.
Traceability alongside authoring.
AI assistance without AI approval.
THE PLATFORM
Your evidence, content
and decisions. Connected.
SAGAREG is designed around a medicinal product and its regulatory lifecycle, not a folder of documents or a chatbot conversation.
Built for regulatory and CMC teams working on generic medicines and biosimilars, with an initial focus on Module 3 and Module 2.3.
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 usable text and tables, retains source identity and location, and presents evidence and candidate facts for review. Unreadable or ambiguous regions are flagged or withheld. Extraction depends on document quality and the configured processing services.
Inspect quality and stability information
Inspect source-derived specifications, analytical methods, process steps and shelf-life statements. Supported stability workbooks retain observations with cell-level lineage and can support study summaries. Scientific conclusions require supporting criteria and an explicit reviewer decision. Complete quality-object-to-dossier claim binding remains roadmap work.
Draft from approved product evidence.
An initial focus on chemistry, manufacturing and controls: Module 3 authoring and the Quality Overall Summary in Module 2.3.
Assist with Module 3 authoring
Draft supported quality sections using approved product evidence, selected templates and applicable reference material. SAGAREG combines deterministic compilers for supported content with governed AI planning and writing. Drafts retain generation context and evidence links. Evidence gaps and validation problems stay visible; generated content still needs human review.
Prepare the Quality Overall Summary
Develop the core dossier’s Module 2.3 summary from supported claims in approved Module 3 revisions. Summary claims retain links to upstream claims and section versions, with separate support review. Application-specific QOS synthesis is not part of the current capability.
Reuse approved company experience
Use approved narrative patterns, prior dossier structures and reviewed authoring corrections within authorized boundaries. Company experience can guide structure and wording; it does not replace evidence for the current product.
Find records and propose work with an assistant
A scoped product assistant can find records, explain saved dossier information with citations, and preview drafting proposals. Work passes through the existing jobs and review process. The assistant does not approve content or treat conversation history as the regulatory record.
A shared core. Explicit market differences.
Keep market applications connected to the core dossier without pretending that every market is identical.
Manage a shared core and market applications
An application can inherit approved core content or maintain an explicit local override. SAGAREG records the core revision behind an override and surfaces when that baseline has moved. Adopting core content creates a draft for the application’s own review rather than automatically approving it.
Make review and readiness inspectable
Examine draft content, source support, validation findings and unresolved material or attachment requirements. Review and approval are distinct recorded actions. Controlled approvals require fresh authentication bound to the action; changed content cannot simply inherit an earlier approval. Readiness findings support reviewer judgement, not a regulatory compliance certificate.
Maintain the dossier as the product evolves.
Connect change assessments, lifecycle records and controlled outputs without discarding earlier regulatory history.
Coordinate changes and lifecycle records
Work with change cases, impact assessments, proposed replacement revisions and reviewed change sets. Supporting workflows connect approved content to market propagation decisions, sequence preparation, filing records, authority outcomes and commitments. Technical review, regulatory approval, authority acceptance and permission to implement remain separate decisions.
Prepare controlled document outputs
Render dossier content and prepare supported eCTD v3.2.2 sequence packages with retained content and lifecycle information. Local checks help identify package problems before handoff. External publishing-tool validation and applicable authority checks are still required. Generating an export is not an authority submission or acceptance.
Current scopeThese capabilities describe implemented product scope, not qualification or availability in every deployment. Deployment availability and customer pilot scope are confirmed separately.
HOW TEAMS WORK WITH SAGAREG
A connected workflow.
From the first source onward.
Gather the evidence. Draft supported content. Make explicit review decisions. Maintain the connections as the product evolves.
- 01
Gather
Organize source material around the product.
- 02
Review evidence
Inspect extraction, candidate facts and source issues.
- 03
Draft
Prepare supported dossier content with evidence links and validation.
- 04
Review and approve
Make explicit decisions against the exact content and context under review.
- 05
Maintain
Track market differences, changes, obligations and controlled outputs.
HUMAN REVIEW, BUILT INTO THE PROCESS
AI assistance
without AI approval.
Drafting and analysis support the team. Governed services and authorized people control regulatory transitions.
Traceability alongside authoring.
Source relationships, retained versions and review history matter as much as the resulting text.
Reuse without replacing evidence.
Approved company experience helps guide new work while factual claims still need current-product support.
PRODUCT ROADMAP
The next
connections.
PLANNED EXTENSIONSThese are planned extensions, not current availability commitments.
Scope, qualification, release sequencing and applicable external validation remain subject to review. No delivery dates are promised.
01More precise change impact across dossiers
Extend qualified dependency tracking across the core, applications and upstream quality records. Further work is needed before promising that only affected chapters become stale in every supported workflow, particularly for stability and QOS dependencies.
02A more connected quality knowledge model
Extend the existing quality-object foundation with deterministic claim bindings, controlled presentation mappings and sealed quality snapshots. Future support for evolving structures, including ICH M4Q(R2), will follow applicable standards, approved mappings and regional readiness.
03Broader biosimilar evidence workflows
Develop richer support for reference biological products, analytical and functional similarity, quality attributes and comparability evidence. Biosimilar development and comparability after a manufacturing change will remain distinct regulatory questions.
04Structured comparisons and requirement applicability
Add richer comparisons between controlled product positions and more explicit assessment of required, conditional and judgement-dependent requirements. Waivers and regulatory conclusions will remain human decisions.
05Additional exchange formats and publishing support
Develop EU eCTD v4.0 test-submission capabilities and a FHIR PQ/CMC export prototype based on sealed records. These are roadmap items, not claims of authority acceptance, production filing enablement or universal interoperability.
06Qualified customer and licensee access
Qualify controlled access to approved, sealed disclosures for external stakeholders, without exposing internal working material or another customer’s information. Production customer sharing is not advertised as enabled.
LET’S TALK ABOUT YOUR WORKFLOW
See SAGAREG in your
regulatory workflow
Tell us where your team spends time reconciling evidence, assembling dossier content or maintaining market differences. We can demonstrate the relevant workflow and discuss what a controlled evaluation would need to establish.