FAQ
Questions clients ask before starting a dossier.
A practical overview of what Everest Nova does, what clients provide, and where regulator decisions remain independent.
Do you submit directly to HSA or MDA?
The launch package prepares the documentation set for client submission. If you need direct submission support, Everest Nova can scope that separately based on product, local-license holder, and market pathway.
Do you prepare pharmaceutical dossiers?
Not in the current launch phase. Pharmaceutical dossier preparation is planned for the next phase; contact us if you would like to register your interest.
Do you guarantee regulatory approval?
No. Everest Nova prepares and organizes documentation. Approval depends on the product, data quality, evidence completeness, manufacturing controls, and regulator assessment.
What do clients need to provide?
Typical inputs include company information, local rights or authorization documents, product description, manufacturer-provided documents, quality files, certificates, labels, IFUs, clinical/performance evidence, risk files, manufacturing information, and prior approvals where available.
How is my dossier preparation price determined?
Everest Nova confirms the device class after intake, and the standard price is then fixed automatically: Class A is SGD 1,999, Class B is SGD 4,999, Class C is SGD 6,999, and Class D is SGD 9,999. Complex or incomplete scopes are custom quoted from SGD 12,000. Government fees and external services are separate unless quoted.
What if I do not know my device class?
Select 'Not sure' during intake. Everest Nova will review the product's intended use, technology, existing approvals, and target market, then confirm the proposed class and exact dossier price before payment is enabled.