Register.
The sponsor organisation registers once for your authority. The first registrant becomes the organisation's administrator and invites colleagues, with delegation controlled by submission type.
CLARALIX FOR NATIONAL REGULATORY AUTHORITIES
Your full mandate on one platform.
Sponsors submit through a single gateway. Your secretariat screens, assigns and corresponds. Assessors work structured questions. Committees decide, and the decision writes itself to the register. Licences, inspections, variations and fees continue on the same record.
THE REGULATORY LIFECYCLE
The regulatory process,
on one record.
Available today↗
Submit.
A guided application form for the submission type, with validation as the sponsor types, dossier upload, fee calculation and a timestamped acknowledgement of receipt.
Screen.
Administrative screening checks completeness against your requirements and records an outcome of accept, refuse, or a tracked request for clarification.
Assess.
Assessors and rapporteurs are assigned, declare any conflict of interest, work your structured question sets and author their assessment reports.
Correspond.
Assessor questions are consolidated into a single list of questions issued to the sponsor as a formal document. The response returns as a tracked cycle and re-assessment follows.
Decide.
The committee meets, considers the agenda and records its outcome. The decision document is produced from your template and signed electronically.
List and maintain.
Approval creates or updates the product record in the register. Variations, renewals, licences and inspections continue against the same record.
ONE RECORD, BOTH SIDES
From the sponsor's form
to the authority's decision.
Illustrative screens from the application and assessment flows. Pick a step.
THE REGULATORY AREAS
Brought into service
according to your mandate.
Claralix is built as separate regulatory areas on a shared foundation. You bring into service the areas your mandate covers. Each area carries its own records, processes and screens.
- Marketing authorisation
- New applications, variations, renewals, unregistered-medicine access, screening, assessment, list-of-questions cycles, committee decision and register listing.
- Clinical trials
- Trial applications, protocol amendments, site submissions, progress and safety reporting, with ethics and regulatory review on the same record.
- Licensing
- Manufacturer, wholesaler, distributor and importer licences, retention fees, renewals, amendments and certificates.
- Inspections
- Request intake, planning, conduct, findings, reports and certification.
- Register and master data
- The product, substance, organisation and reference data master, with governed change and public listing.
- Fees and finance
- Fee schedules, calculation, invoicing, payment gating and financial reporting.
- Committees
- Agendas, consents, conflict declarations, controlled document access and minuted outcomes, used for medicines control committees, technical committees, clinical trials committees, research ethics committees and advisory committees.
KNOW WHAT YOU ARE EVALUATING
Clear scope.
From the start.
Available today
In use in a live regulatory deployment. We will demonstrate it on request.
Sponsor intake, screening, assessment, committee decisions and records.
Configured by your administrators
Present in the platform and brought into service by your own staff through configuration, without software changes.
Forms, workflows, fees, branding, joint assessment and ethics review.
Delivered as an implementation service
Requires work in your environment, typically connection to your identity, finance, records or monitoring systems, or the preparation of assurance evidence. Scoped and priced per engagement.
Enterprise identity federation, finance connections and protected regulatory record retention.
Planned
Not available. On the published roadmap or built to order. Never presented as current.
Drag-and-drop workflow canvas, second-person configuration approval and offline inspection capture.
CONFIGURATION OWNERSHIP
Your administrators
own the process,
not your vendor.
Application forms, workflow templates, question sets, document and notification templates, fee schedules, catalogues and role entitlements are maintained by your own staff in the administration area. Changes are versioned and take effect without a software release. Applications already in progress continue on the version under which they were submitted.
This is the difference between a platform an authority operates and a system an authority waits on. Configuration ownership transfers to your team at go-live, and your administrators are paired with ours from the start of the engagement.
Forms, workflows & question sets 01Documents & notifications 02Fees, catalogues & entitlements 03
A RECORD YOU CAN ACCOUNT FOR
Human decisions.
Recorded clearly.
Available today01Every case carries a complete action history: who acted, in what role, at which stage, and when.
02Submissions are locked to the form version under which they were made.
03Decisions are recorded with actor, role and outcome, and issued as verifiable documents.
04No automated component makes or gates a regulatory decision. Every decision is a human act, attributed.
Delivered as an implementation service
Retention rules are agreed at design. Exemption from routine log and audit pruning, and tamper-evident storage where required, are scoped for your deployment.
START WITH YOUR PROCEDURE
Bring a representative form
and a process map.
In the demonstration we will show how configuration works against your own material, and we will be explicit about anything that would require configuration effort, an integration, or development. You will leave knowing which is which.