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Fiverr Pro
English
$
USD
I will do fda otc drug registration, ndc, spl and us agent service
About this Gig
Launch your FDA OTC drug or peptide brand without the stress of regulatory rejections. Errors in NDC configuration or SPL XML submissions can trigger FDA warning letters, Amazon removals, and permanent import bans.
I am a Regulatory Affairs expert specializing in FDA registration and FDA compliance. I ensure your products meet all U.S. federal requirements for a smooth market entry.
My Services:
- FDA OTC Drug Registration & Establishment Listing
- NDC Number Assignment & Labeler Code Setup
- SPL XML Submission for DailyMed
- US Agent Service for Foreign Companies
- Label Review (Drug Facts, Warnings, Active Ingredients)
- FDA Product Listing & MoCRA Compliance
- Peptide & Research Chemicals Regulatory Support
Why Work With Me?
- Amazon & TikTok Shop Ready: Avoid restricted product flags.
- 100% Acceptance: Expert handling of 21 CFR standards.
- Fast Turnaround: Get compliant in 48-72 hours.
Message me now to secure your U.S. market launch!
Type of Business:
LLC
•
LTD
Service type:
State business registration
Target country:
Worldwide
•
United Kingdom
•
United States
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.
FAQ
What is an NDC number and do I need one?
The National Drug Code (NDC) is a unique 10-digit, three-segment number which serves as a universal product identifier for drugs. If you are selling OTC drugs in the U.S., you must have an NDC number assigned and listed with the FDA.
What is SPL filing?
Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by the FDA. It is the mandatory format for submitting drug establishment registration and drug listing information.
Can you help if my product was removed from Amazon?
Yes. Amazon often removes products due to missing NDC numbers or incomplete FDA listings. I can audit your current status, fix the compliance gaps, and provide the documentation needed to reinstate your listing.
How long does the registration process take?
Establishment registration is typically processed within 48-72 hours once all information is submitted. Drug listing and SPL validation may take slightly longer depending on the complexity of the ingredients and labeling.
