Dossier readiness and gap assessment
We check your dossier against SAHPRA requirements and close gaps before submission, not after a rejection.
SAHPRA registration support that gets you to approval
Registering a medicine or health product with SAHPRA is where timelines slip and capital burns. Veltrion coordinates the dossier, submission and lifecycle so registration moves on defined milestones, not open-ended delay.
The real cost of a SAHPRA delay is not the fee. It is the months of stalled revenue. Veltrion exists to compress that timeline.
How Veltrion supports your SAHPRA registration
Submission and query management
We manage the submission and the back-and-forth so queries are answered fast and correctly.
Classification and pathway
We confirm the right classification and registration pathway for your product.
Lifecycle and variations
We maintain the registration: renewals, variations and ongoing compliance.
Common questions
How long does SAHPRA registration take?
Timelines vary by product class and dossier quality. The single biggest lever is a complete, correctly classified dossier at submission, which is exactly what we coordinate.
What do you need from us to start?
Your existing dossier or product file and target market. We assess readiness first and tell you the real gaps before any submission.
Do you handle medical devices and IVDs too?
Yes. We support registration and establishment requirements for medicines, medical devices and IVDs under the relevant SAHPRA frameworks.
Tell us the market and the date.
Most of these resolve in one call. If there is no route worth taking, we say so on the call.