Private beta · Saudi organizations
RegDossier Cloud — regulatory, quality & excellence workspace.
Keeps dossiers, evidence, authority replies, and follow-up notes together so teams can review and respond without noise.
SFDA dossiers (eCTD)
Accreditation & quality (CBAHI, ETEC)
Excellence tracks (KAQA)
Regulatory dossiers
Structured workspaces for sequences, authority Q&A, and readiness checks in one place.
- Sequence control, validation, and cross-references.
- Authority conversations logged beside submissions.
Quality & accreditation
Evidence tied to standards with audit trails and role-based access.
- Criteria-by-criteria evidence with ownership and status.
- Dashboards that keep teams inspection-ready.
Excellence programs
Repeatable setups for KAQA and institutional excellence without scattered files.
- Templates for enablers, results, and supporting proof.
- Linked evidence reused across multiple criteria.
Core ideas
- Regulatory-first over generic drives and chat.
- Evidence linked directly to dossier requirements.
- Arabic/English ready with audit trails and versioning.
- Private beta with hands-on setup for early teams.
Built for
- Regulatory affairs teams preparing SFDA submissions.
- Quality and accreditation leads maintaining continuous readiness.
- Consultants supporting multiple clients without scattered folders.
- Excellence units aligning proof to national programs.
Ready when you are
Controlled private beta with select Saudi organizations. Focused on delivery, not noise.