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Fiverr Pro
Nederlands
$
USD
I will handle fda 510k submission, device listing, ndc, fda registration and compliance
Precision driven compliance guru turning FDA complexity into clarity
Hello and welcome. I’m Alex Loveth, a certified Regulatory Affairs Expert with FDA specialization and an 87.3% success score in approvals. I simplify complex compliance with FDA registration, DUNS set...
Niveau 1
Voldoet aan bepaalde prestatiecriteria en toont een sterke potentie op de marktplaats.
Over deze dienst
DISTINGUISHED BUYER, WELCOME!
Navigating FDA regulations can be complex, but with an experienced regulatory expert, your pathway to approval becomes seamless. I provide FDA regulatory consulting specializing in 510(k) submission, medical device compliance, and regulatory documentation review, ensuring your products meet FDA standards accurately and efficiently.
I serve multiple FDA regulated industries, including medical devices, pharmaceuticals, cosmetics, and food products, supporting everything from facility registration, device listing, DUNS/UFI registration, NDC code acquisition, to pre-submission consulting and regulatory strategy.
Services I Offer:
- FDA facility registration & device listing
- DUNS/UFI registration assistance
- 510(k) preparation, submission & FDA reviewer follow-up
- GUDID medical device registration
- NDC code acquisition & drug listing
- FDA reporting & vigilance support
- Pre-submission consultation & compliance strategy
- Regulatory documentation review
- Labeling compliance (medical, drug, cosmetic, food)
Lets make your FDA approval journey smooth, fully compliant, and professionally managed today.
BEST REGARDS.
Productfase:
Ideeënvorming
•
prototype
Type product:
Fysieke producten
Branche:
Medisch en farmaceutisch
Doelland:
Wereldwijd
Mijn portfolio
Veelgestelde vragen
Do you assist with full FDA 510(k) preparation and submission?
Yes. I prepare, compile, format, and submit your complete 510(k) dossier and handle all reviewer follow-up until FDA clearance.
Can you help determine the correct device classification?
Absolutely. I analyze your product, compare predicate devices, and confirm the proper FDA classification and regulatory pathway.
Do you support DUNS, UFI, and FDA facility registration?
Yes. I assist with obtaining DUNS/UFI numbers, facility registration, and device listing under FDA requirements.
Can you help with NDC codes for drug products?
Yes. I support NDC code acquisition, drug listing, and compliance for registered drug establishments.
Do you work with cosmetics, food products, or pharmaceuticals?
Yes. I provide FDA regulatory support across medical devices, cosmetics, food products, OTC drugs, and supplements.
Do you offer follow-up with FDA reviewers?
Yes. I manage reviewer questions, additional information requests, and pre-submission support.
What if my documentation is incomplete?
I can help you prepare missing documents, labeling, testing summaries, risk files, and compliance reports.
Reviews
9 reviews van deze dienst
| (9) | ||
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Specificering van de beoordeling
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Meest relevant
A andresem62
Zwitserland
Alex, helped us to clarify the very complex FDA classification of our medical device
US$ 50
Prijs
4 dagen
Looptijd
Nuttig?J johnson88_lu
Singapore
I have received the questions asked.
US$ 200-US$ 400
Prijs
8 dagen
Looptijd
Nuttig?N nikoowashere
Verenigde Staten
Alex was very helpful and an amazing communicator. look forward to working with her again.
US$ 200-US$ 400
Prijs
6 dagen
Looptijd
Nuttig?M 
macleender
Verenigde Staten
Honestly, this was a really smooth experience from start to finish.Alex was very responsive and took the time to explain everything clearly, which I really appreciated. I never felt confused at any point, she made the whole process easy. The final delivery was spot on well done, detailed, and exactly...
US$ 50
Prijs
4 dagen
Looptijd
Nuttig?M macleender
Verenigde Staten
Working with Alex was a great experience. Communication was clear, fast, and very professional throughout the entire process. Every question I had was answered in detail, which made everything easy to understand. The work she delivered was excellent,well structured, accurate, and completed exactly as...
US$ 50
Prijs
4 dagen
Looptijd
Nuttig?
Reviews
9 reviews van deze dienst
| (9) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Specificering van de beoordeling
- Communicatieniveau van de freelancer
- Kwaliteit van de levering
- Waarde van de levering
Sorteer op
Meest relevant
A andresem62
Zwitserland
Alex, helped us to clarify the very complex FDA classification of our medical device
US$ 50
Prijs
4 dagen
Looptijd
Nuttig?J johnson88_lu
Singapore
I have received the questions asked.
US$ 200-US$ 400
Prijs
8 dagen
Looptijd
Nuttig?N nikoowashere
Verenigde Staten
Alex was very helpful and an amazing communicator. look forward to working with her again.
US$ 200-US$ 400
Prijs
6 dagen
Looptijd
Nuttig?M macleender
Verenigde Staten
Honestly, this was a really smooth experience from start to finish.Alex was very responsive and took the time to explain everything clearly, which I really appreciated. I never felt confused at any point, she made the whole process easy. The final delivery was spot on well done, detailed, and exactly...
US$ 50
Prijs
4 dagen
Looptijd
Nuttig?M macleender
Verenigde Staten
Working with Alex was a great experience. Communication was clear, fast, and very professional throughout the entire process. Every question I had was answered in detail, which made everything easy to understand. The work she delivered was excellent,well structured, accurate, and completed exactly as...
US$ 50
Prijs
4 dagen
Looptijd
Nuttig?
