Ingest & comparison
Bring together the registered Module 3 baseline and current manufacturing source documents. The platform performs a structured, evidence-backed comparison rather than ad-hoc folder reviews.
Gap analysis
Systematic identification of deviations from the approved state, with traceable differences your reviewers can challenge, accept, or refine — aligned with how CMC teams actually defend a file.
Regulatory classification
Each detected change can be carried through Type IA, IAIN, IB, and II style classification with EU variation coding and citation support — designed to reduce rework before agency-facing review.
CTD Module 3 authoring
Generate updated Module 3 sections with clean and tracked-change views, regulatory-grade wording, and preserved structure compatible with common CTD / ICH M4Q expectations.
Submission package outputs
Produce change summaries suitable for eAF workflows, supporting document maps, and audit-ready decision logs so the story of “what changed and why” survives internal QA and external scrutiny.
Dashboard
A central landing area for signed-in users. Visibility is controlled by authorisation policy so users only see navigation and screens their role allows.
User management
Tenant-scoped directory of users with create, view, and update flows where policy permits. Active and inactive states help control who may sign in, and first-login password changes can be enforced for new accounts.
Authorisations
Administrators configure which roles may view, create, edit, or delete access to major areas of the product. New role names can be introduced and then granted specific form rights alongside broader administrator versus staff separation.
Experience
A consistent dark theme with high-contrast typography, tuned for long document and compliance workflows on desktop browsers.