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I will handle fda otc listing ,regisration and compliance , mocra product listing
FDA Regulatory Compliance Specialist
I’m Anderson, an FDA Regulatory Compliance Specialist helping brands successfully enter the U.S. market. I specialize in FDA OTC drug registration, cosmetic and supplement compliance, facility registr...
About this Gig
Are you preparing to launch an Over-The-Counter (OTC) product in the U.S. and need expert guidance through the FDA registration process? I specialize in helping businesses navigate FDA OTC drug listing and compliance with precision and professionalism.
Who Needs This Service?
My expertise is valuable for:
- Pharmaceutical companies
- Nutraceutical and supplement brands
- Cosmetic and personal care manufacturers
- International businesses seeking U.S. market entry and requiring a U.S. agent
- Amazon / Shopify / Walmart sellers
- Private label brands
What I Offer:
- FDA Establishment Registration
- OTC Drug Listing submission (SPL format guidance)
- 510(k) Submission Support
- FSVP, NPN & Barcode Integration
- Ongoing Regulatory Compliance
- U.S. Agent Services for Foreign Firms
Whether you're a startup or an established brand, I provide tailored support to ensure your product meets FDA requirements efficiently and accurately. My services are designed to simplify complex regulatory steps and help you avoid costly delays.
Why Choose Me?
- Proven experience in FDA regulatory processes
- Fast, reliable communication
- Clear documentation and guidance
Let's get your product listed and FDA Registered
Type of Business:
LLC
•
LTD
Service type:
State business registration
Target country:
Worldwide
Business formation & registration Gigs are not screened
Fiverr does not pre-screen freelancers offering services in Business Formation & Registration. We advise thoroughly reviewing freelancer profiles, asking questions, and confirming their qualifications to ensure they meet your requirements. Freelancers marked as “Pro” have completed a vetting process for added confidence. Learn more here.
My Portfolio
FAQ
What documents do I need?
Typically product details, labeling information, and compliance forms. I’ll provide a checklist tailored to your product.
Can you work with international clients?
Yes, I can assist clients worldwide who want to list OTC products with the FDA.
Can you fix rejected listings?
Yes, I can review, correct, and resubmit.
Do you guarantee FDA approval?
I provide guidance and documentation support, but the FDA makes the final decision.
What is the FDA OTC listing, and why do I need it for my product?
The FDA OTC listing ensures that your product complies with FDA regulations and is safe for consumers. It’s required for legally marketing OTC drug products in the U.S.
What is MOCRA, and how does it impact my product?
MOCRA regulates cosmetics and skincare products in the U.S., requiring proper FDA listing, ingredient safety, and accurate labeling to avoid compliance issues.
What documents are required for FDA OTC listing and MOCRA compliance?
Documents needed include product formulations, ingredient lists, labeling details, and manufacturing information. I assist in gathering and organizing these for proper submission.
How do I ensure my product label complies with FDA regulations?
I review labels to ensure correct Drug Facts panels, verified claims, ingredient accuracy, allergen statements, and compliance with FDA readability standards.
Can you help me with FDA compliance for both OTC drugs and cosmetics?
Yes, I provide compliance services for both OTC drugs and cosmetics to ensure they meet FDA and MOCRA regulations.
