SAHPRA
South African Health Products Regulatory Authority
CLARALIX / REGULATORY INFORMATION MANAGEMENT
One record,
from submission
to decision.
Claralix is the platform a medicines regulator or an ethics committee runs its applications on. Sponsors and researchers submit through one gateway; your staff screen, assess and decide; the decision and everything behind it stay on one record.
01 / THIS IS CLARALIX
The platform, as the applicant
and the authority see it.
Five screens from the application and review flows, from the first form to the committee’s decision. Illustrative content. Pick a step.
02 / TWO WAYS TO DEPLOY
One platform.
Two kinds of authority.
One platform. The submission types, review questions, meeting cycle and decision templates are configured to each organisation’s mandate. Choose yours to see how it runs.
01 / REGULATENational regulatory
Research ethics
National regulatory
authorities
Submission intake, screening, assessment, committee decisions, licensing, inspections, fees and a product register on one record.
02 / REVIEWResearch ethics
committees
Protocol submission, administrative screening, reviewer assignment, committee meetings, minuted decisions and continuing review, on one record.
For regional and continental agencies
Joint and shared assessment across contributing authorities, standardised reports and reliance status. Each authority has its own deployment; cross-authority sign-in requires an implementation service.
↗For sponsors and applicants
Register your organisation, submit applications, respond to questions and follow progress through your authority’s gateway. Registration is per authority.
↗03 / ONE PLATFORM. YOUR IDENTITY.
Your identity.
Your platform.
Powered by Claralix.
White-label colours, logos and typography across the portal, documents and emails. Your organisation’s identity leads, with a discreet Claralix endorsement.
Authority portal · Illustrative client theme
Configured by your administratorsAPPLICATION / CLR-2026-014
Marketing authorisation
Example Health · Illustrative application
A guided application
STEP 02 / APPLICATION DETAILSSubmission type
Marketing authorisation ⌄
Applicant organisation
Example Health
Application reference
CLR-2026-014
SUPPORTING DOCUMENTS
PDF
Application form.pdfAdded to this application
PDF
Quality dossier.pdfAdded to this application
The application and its documents stay together on one record.
A structured assessment
ASSESSOR WORKSPACE01
Quality documentation
Review the submitted dossier against the authority’s question set.
In review02
Supporting information
Record questions for the sponsor in the case correspondence.
ASSESSMENT NOTES
Clarification requested on the supporting documentation.
Assigned assessorRole recorded with the action
PDF
Quality dossier.pdfLinked application document
A decision with its history
COMMITTEE RECORDRECORDED OUTCOME
Approved
Illustrative committee outcome
- Decision by
- Authorised committee
- Application
- CLR-2026-014
- Record
- Linked to the product register
CASE HISTORY
- Submission receivedSponsor organisation
- Assessment completedAssigned assessment team
- Decision recordedAuthorised committee
Client identity leads.The Claralix mark stays neutral.
In regulatory use across marketing authorisation, variations, unregistered-medicine access, clinical trials, licensing and inspections.
WHERE CLARALIX IS IN USE
Regulators across the continent.
SOUTH AFRICA
PharmaEthics
Pharma-Ethics independent research ethics committee
NIGERIA
NAFDAC
National Agency for Food and Drug Administration and Control
04 / THE REGULATORY LIFECYCLE
The regulatory process,
on one record.
Available todayRegister.
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.
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.
05 / 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.
06 / 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
07 / 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.