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Roadmap for US Market Entry

PHASE 1: Foundational Legal & Regulatory Setup – Must-Haves Before Importing
FDA Facility Registration + U.S. Agent Representation + D-U-N-S® Registration + FSVP Agent Basic Service View Service
Food Facility and D-U-N-S® Registration Services View Service
D-U-N-S® Number Processing Service View Service
Food Facility/Renewal Registration Service View Service
FDA/USDA – FSVP & FSMA Starter Package: Coaching, Consultancy, and Advisory Support View Service
FSVP Requirements Compliance Management Set-up for Importers View Service
Foreign Supplier Verification Program (FSVP) – Toolkit View Service
FSVPQI / U.S. Agent Representation Services View Service
FSVPQI Implementation Support Services View Service
FSVP Agent Representation for Foreign Suppliers View Service
FSVPQI End-to-End Monthly Remote Supplier Compliance Management Subscription View Service
PHASE 2: Supplier & Product Compliance Validation
FSVP and FFVA Annual Supplier Compliance Assessment Services View Service
Imported Food Product List Regulatory Review for U.S. Compliance Requirements View Service
FDA Prior Notice Filing and Submission Services for U.S. Food Imports View Service
FSVP Documentation Tools Set-Up for Exporters to the U.S. View Service
FSVP Requirements Compliance Management Set-up for Exporters View Service
FSVP Requirements Compliance Management Set-up for Brand Owners View Service
Pre-FDA Inspection Compliance Review & Facility Gap Assessment – Food and Beverages View Service
PHASE 3: Product & Label Compliance Setup
Product Label Regulatory Review Compliance Assessment View Service
Product Label Development – Nutrition Facts or Supplement Facts Panel View Service
cGMP & HARPC Compliance SOP Templates for Human Food View Service
cGMP & HARPC Compliance SOP Templates for Animal Food View Service
Product Acceptance and Release SOP Templates View Service
Vendor Compliance and Certification Support Services View Service
FSVP Compliance Management System Software View Service
PHASE 4: Supplements-Specific (if applicable)
Dietary Supplement Facility Registration Services View Service
Dietary Supplement GMP Compliance SOP Templates View Service
Website Content Regulatory Review for Dietary Supplements View Service
Pre-FDA Inspection Compliance Review & Facility Gap Assessment – Dietary Supplements View Service
PHASE 5: Additional Risk-Based or Brand-Credibility Services
California Proposition 65 Regulatory Review View Service
California Slack Fill Requirements Regulatory Review View Service
FDA Warning Letter Response Service View Service
Beneficial Ownership Information Report (BOIR) Compliance Filing Service View Service
Case Study Development Services View Service
Product Rebranding Compliance Package View Service
Trademark Registration Services View Service

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.