Regulatory outcomes
Dossier gap analysis
Bring together the registered Module 3 baseline and current manufacturing source documents. Systematic identification of deviations from the approved state, with traceable differences reviewers can challenge, accept, or refine.
Change control assessment
Assess regulatory impact of manufacturing and quality changes — identify which filings are required before a change proceeds, so CMC and RA stay aligned on risk.
Variation classification
Carry each detected change through Type IA, IAIN, IB, and II classification with EU variation coding, grouping and worksharing considerations, and citation support.
Module 3 authoring
Generate updated Module 3 sections with clean and tracked-change views, regulatory-grade wording, and structure compatible with CTD / ICH M4Q expectations.
Submission package outputs
Produce change summaries suitable for eAF workflows, supporting document maps, and audit-ready decision logs so “what changed and why” survives internal QA and external scrutiny.
Platform administration
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 focused application UI tuned for long document and compliance workflows on desktop browsers — separate from this public marketing site.