Site registration with FDA (Food and Drug Administration) is a mandatory process for all facilities that manufacture, process, or hold certain products for commercial distribution in US including drugs, dietary supplements, and cosmetics. This process involves both facility registration and product listing and must be completed via the FDA Industry System (FIS).

Any domestic or foreign establishment that manufactures, imports, reprocess or develops specifications for medical devices sold in US must also register with FDA.

We make this process easy by helping our clients to complete this process smoothly and efficiently.

AlephAstra LLC

info@alephastra.com

site.registration@alephastra.com