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I will be your f d a lawyer
FDA Expert
I am an FDA regulatory compliance consultant specializing in FDA 510(k) submission, FDA registration, device listing, NDC code acquisition, DUNS/UFI registration, GUDID registration, labeling complian...
About this Gig
Navigating complex federal parameters can be challenging for medical and retail brands. I provide expert professional consulting for your official fda registration, structural fda compliance, device listing, and technical documentation audits. Whether you are launching a new device or importing consumer items, I streamline your paperwork to keep your business fully protected.
Avoid costly logistics rejections, marketplace platform removals, or warning letters by preparing your files correctly before submission. My comprehensive audits target regulatory inconsistencies, layout vulnerabilities, and missing mandatory filings.
Services Offered:
- FDA Registration & Renewal Support: Complete facility profiling and listing.
- Medical Device Support: Regulatory clearance pathways, including complex 510(k) file mapping.
- Technical Identifiers: Guidance for DUNS/UFI registration, GUDID setup, and official NDC codes.
- FDA Label Review: Deep-dive analysis of packaging, panel claims, and formatting structures.
- US Agent Services: Serving as the mandatory domestic point of contact for overseas companies.
Please contact me before ordering to map out your specific pathway!
Type of Business:
LLC
•
S-corp
Service type:
Initial licensing and permits
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
1. What FDA services do you provide?
I provide support for FDA registration, FDA facility registration, FDA compliance review, FDA 510(k) submission support, device listing, DUNS/UFI registration, GUDID registration, NDC code assistance, labeling compliance review, regulatory documentation review, and regulatory strategy for FDA-regula
2. Can you help with FDA 510(k) submissions?
Yes. I provide FDA 510(k) submission support, regulatory pathway analysis, documentation review, device classification guidance, and assistance throughout the submission process to help ensure your medical device meets FDA requirements before submission.
3. Do you assist with FDA device listing and facility registration?
Yes. I can assist with FDA facility registration, medical device establishment registration, device listing, registration updates, and related compliance requirements for manufacturers, importers, distributors, and FDA-regulated businesses.
4. What industries do you support?
I support medical devices, pharmaceuticals, drugs, cosmetics, food products, dietary supplements, and other FDA-regulated industries. Services are tailored to the specific regulatory requirements applicable to your product category.
5. Can you help obtain a DUNS/UFI number or NDC code?
Yes. I provide guidance and support for DUNS/UFI registration requirements, National Drug Code (NDC) assistance, and related regulatory registrations needed for FDA submissions, listings, and compliance activities.
6. Do you review product labels for FDA compliance?
Yes. I perform FDA labeling compliance reviews for medical devices, drugs, cosmetics, food products, and dietary supplements to identify potential compliance issues and help align labels with FDA requirements.
7. What do you need from me to get started?
Typically, I will need product details, company information, existing registrations (if any), product labels, technical documentation, intended use information, and any FDA correspondence related to your project. Requirements vary based on the service selected.
8. Should I contact you before placing an order?
Yes. Every product and FDA pathway is different. Contacting me before ordering allows me to review your requirements, determine the appropriate regulatory pathway, and recommend the best package for your FDA registration, device listing, or 510(k) submission needs.
