Transparent medical device dossier pricing.

Everest Nova AI uses structured project information and the uploaded file inventory to identify likely missing or unclear document categories, prioritize follow-up requests, and help the team move into expert review with a more organized starting point. AI supports the workflow; it does not make the final regulatory judgment.

No. AI accelerates initial readiness screening and question preparation. Everest Nova's medtech experts review the project context, verify AI-assisted findings, make regulatory judgments, and control the dossier delivered to the customer.

No. Everest Nova AI does not predict approval, provide legal advice, or guarantee an authority outcome. It helps identify documentation categories that may need attention before expert review.

The package includes classification confirmation, pathway identification, structured intake, review of customer-provided documents, an initial gap assessment, a country-specific checklist, dossier preparation, medtech regulatory expert review, one consolidated revision cycle, the final downloadable package, project tracking, and portal access.

No. Government, regulatory authority, CAB, licensing, registration, and other third-party fees are separate from Everest Nova professional fees. Customers pay those fees directly where applicable. Everest Nova does not pay them on behalf of customers.

No. Everest Nova prepares submission-ready documentation but does not directly submit applications to regulatory authorities.

No. Everest Nova does not provide laboratory testing.

No. Everest Nova does not provide certified translation services.

No. Everest Nova prepares and organizes documentation. Approval depends on the product, data quality, evidence completeness, manufacturing controls, and regulator assessment.

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.

Each market has its own regulatory workflow, dossier adaptation requirements, and operating structure. Singapore dossier fees are listed in SGD, while Malaysia dossier fees are fixed in MYR. These are Everest Nova professional fees only.

The bundle uses one shared regulatory foundation, adds country-specific adaptation, and runs through one coordinated workflow. It includes a modest saving compared with purchasing both country packages separately.

Singapore Registrant Support is an optional service for eligible applications priced at SGD 300 per application. Government and authority fees are not included.

Malaysia Authorized Representative Support is an optional service for eligible applications priced at SGD 300 per application. MDA, CAB, and other third-party fees are not included.

Yes. Eligible add-ons can be purchased from your Everest Nova account and attached to your existing project.

An additional eligible product variant receives 40% off the applicable dossier price, so the customer pays 60%. Everest Nova must first confirm that the technical documentation and regulatory scope are sufficiently shared.

Start with the SGD 250 Regulatory Pathway Assessment. It provides a preliminary classification, recommended pathway, high-level requirements, and next steps. The assessment fee is credited toward an eligible dossier package purchased within 30 days.