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I will do fda drug registration and ndc listing support
Clear FDA filings and compliance for confident market entry
I help food, cosmetic, medical device, drug, and supplement businesses organize accurate FDA registration, listing, compliance, and U.S. market entry work. My service is detail focused and transparent...
About this Gig
Are you in need of an FDA drug establishment registration, NDC listing, SPL submission support, US agent coordination or eDRLS readiness? I help pharmaceutical manufacturers, private label drug businesses, importers, and regulatory teams organize the information used for a clean U.S. registration and listing workflow.
I can review establishment roles, product names, labels, active ingredients, NDC related data, manufacturing locations, US agent and importer details, and update history, identify missing fields and create a structured submission checklist. Premium scope adds a multi-product tracker, June/December update calendar, and data quality gap matrix.
FDA registration or listing does not mean a product is approved and this service does not guarantee NDC publication, FDA acceptance or legal compliance.
Send your product type, establishment role, label, manufacturing country, current records, and target launch date before ordering so I can confirm scope.
Type of Business:
LLC
•
General Partnership
Service type:
State business registration
Target country:
Australia
•
Canada
•
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
Can you register a drug establishment with FDA?
I can organize the establishment information, product inventory, responsible contacts, and submission checklist. The registrant remains responsible for validating and authorizing the official electronic submission.
Can you create an NDC number?
I can help organize NDC-related information and identify missing listing data. I do not promise that an NDC will be assigned, published, or accepted because that depends on FDA procedures and product facts.
Do you work with SPL files?
Yes. I can review requested structured data fields, organize source information and create a readiness checklist for SPL submission. Full technical SPL authoring or software work should be scoped separately.
Can you list several drug products?
Yes. Standard and Premium packages can cover multiple products if the product count and data condition are agreed before ordering. Each product needs an accurate label and current manufacturing information.
Do you handle June and December updates?
I can create an update calendar and prepare a data-change checklist for the recurring June and December cycle. You remain responsible for confirming changes and authorizing timely submission.
Can you act as the U.S. agent for a foreign drug company?
I can coordinate the information needed for a US agent and help organize contact data. Acting as an official agent requires a separate agreement and is not automatically included.
Will drug registration prove FDA approval?
No. FDA states that establishment registration and drug listing do not indicate product approval or FDA verification of the submitted information. Approval and listing are distinct regulatory matters.
Can you review our drug label?
Yes. I can check data consistency and flag obvious gaps relevant to the registration/listing workflow. This is not a labeling approval or legal opinion.
Can you support OTC products and supplements?
I can perform an initial classification and data intake review. OTC drugs, dietary supplements, and cosmetics follow different rules, so I will confirm the category before accepting the order.
What documents are needed to start?
Send the establishment details, product labels, active-ingredient information, manufacturing locations, current registration/listing records, US agent/importer details, and target launch or update date. I will confirm the package and any missing inputs.
