Dossier Management
Country by country, submission by submission
A product registered in fifteen countries has fifteen dossiers, each at a different stage, each with its own variations. This module holds the index, the compilation, the submission and the approval per country, so regulatory affairs stops tracking it in a spreadsheet.
What Dossier Management covers
Structure
- Country-specific dossier index against the product master
- CTD format dossier forms with module-wise section control
- Dossier compilation from the document repository
Lifecycle
- Submission workflow with receipt, query and response tracking by country
- Approval, renewal and variation management
- Product master linkage so a formulation change surfaces the dossiers it affects
What the system notices for you
Suggestions only. Nothing here signs, approves or dispositions anything — a qualified person decides and the audit trail records who. Every model shows the data behind its suggestion, and every feature can be switched off per site.
Change impact mapping
When a specification, supplier or process changes, lists every dossier and country affected.
Query response drafting
Assembles a first response to a regulatory query from your existing dossier content.
Renewal horizon
Tracks expiry and variation deadlines across the portfolio and warns early.
Dossier Management — common questions
Does it support the CTD format?
Yes, with module-wise section control and compilation from the document repository, indexed per country.
What happens when a formulation changes?
Change impact mapping lists every dossier and every country affected by a specification, supplier or process change, so regulatory affairs is not reconstructing that from memory.
Works with
Every module shares one database, so nothing below is an integration — it is the same record seen from a different desk.
Financial Management
A full ledger, not an export to somebody else's accounting package
Read more EDeDocument Management
Every attachment findable, none of it slowing the system down
Read more HRTime Office & Payroll
Shifts, attendance and salary for a plant that runs around the clock
Read more UAUser Administration
Role-based access, electronic signature and an audit trail that holds up
Read moreSee it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.