Documentation help
What to prepare before uploading files.
Every product is different, but these categories help clients begin with a cleaner dossier intake.
Company information, local rights, commercial authorization, and contact details
Manufacturer-provided documents, certificates, technical files, and supporting evidence
Product description, intended use, specifications, or device technical summary
Certificates, quality-management evidence, GMP/ISO references, and manufacturing-site details
Labels, IFUs, packaging artwork, product information, and claims support
Clinical, performance, stability, safety, risk, and post-market evidence where relevant
Prior approvals, certificates of free sale, and reference-market documentation