Foundational Setup

Acquisition of the DUNS Number, the essential global identifier for the US regulatory system. We ensure data consistency across all future FDA and State filings to prevent costly delays.

Federal Market Access (FDA)

• Medical Devices: 510(k) submissions, 21 CFR 820 Quality Systems (QSR), and Official US Agent representation.
• Food & Supplements: Food Facility Registration (FFR), label reviews, and claim verification.
• OTC Drugs: Drug Facts label audits, Labeler Code applications, and SPL file management.

Operations & Protection

• Audit Readiness: Mock FDA audits and expert representation during on-site inspections.
• Logistics Support: Handling Import Holds and verifying warehouse compliance.
• Brand Protection: USPTO trademark searches, filings, and legal maintenance.

California State Compliance

Managing complex local requirements including California Board of Pharmacy Wholesaler Licenses and CDPH Processed Food Registrations (PFR).