I will do fda registration, 510k dossier, 21 cfr 820 qms, and fda audit support

Adeniran J

United States

I speak English
As a certified and experienced business registration expert, I specialize in forming USA LLCs for both U.S. residents and non-residents. Whether you need help with EIN, BOI (Beneficial Ownership Infor...
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About this Gig

Are you launching a medical device or health product in the U.S. market?

Stay compliant and avoid costly FDA rejections or delays I'm here to help!


I'm a regulatory compliance specialist with in-depth knowledge of FDA registration, 510(k) submissions, 21 CFR 820 quality systems, and FDA audit preparation.


I've worked with international manufacturers, U.S.-based suppliers, and startups needing guidance through the regulatory maze.


Services I Offer:

  • FDA Registration & Device Listing
  • 510(k) Dossier Creation & Submission
  • 21 CFR 820 Quality Management System (QMS) Documentation
  • FDA Audit Preparation (Mock Audits, CAPA Plans, Checklists)
  • FDA Labeling & Packaging Review (Food, Supplements, Devices)
  • Risk Assessment, Design Controls, SOPs
  • US Agent Service for Non-US Companies
  • QMS Templates (CAPA, Complaint Handling, Internal Audit, etc.)
  • Regulatory Strategy Consulting


Why Choose Me?

  • Experienced FDA regulatory professional
  • Audit-Ready documentation
  • US & international client support
  • Prompt communication
  • 100% Confidentiality guaranteed
  • Compliance with FDA, ISO 13485, 21 CFR 820


Please message me so I'll review your needs and offer the best guidance to help you get FDA compliant.

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do fda registration, 510k dossier, 21 cfr 820 qms, and fda audit support
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do fda registration, 510k dossier, 21 cfr 820 qms, and fda audit support
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Type of Business:

LLC

•

General Partnership

Target country:

Worldwide

•

United Kingdom

•

United States

Service type:

State business registration

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