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bastienjorahk

Bastien J

@bastienjorahk
4,7(1)
Verenigde Staten
Engels, Duits
Sommige informatie wordt in het Engels weergegeven.
Over mij
I am a detail-oriented and results-driven professional with a focus on delivering high-quality work efficiently and accurately. I value clear communication, reliability, and building trust with every client. My goal is to provide solutions that meet your needs while maintaining professionalism and consistency.... Lees meer

Skills

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bastienjorahk
Bastien J
offline • 
Gemiddelde reactietijd: 1 uur

Bekijk mijn diensten

Bedrijfsregistratie
I will handle fda compliance, fsvp, US agent, 510k dossier, and label review
4,7(1)
Goedkeuring FDA en voedselveiligheid
I will register your food facility with fda and set up fsvp compliance

Werkervaring

FDA Setup

Feza • Freelance

Aug 2024 - May 20259 mos

With over 7 years of dedicated experience in US regulatory affairs and compliance, I have successfully guided medical device, pharmaceutical, and biotech formulations through critical FDA milestones. My background spans hands-on technical dossier compilation, rigorous gap analyses, and direct preparation for complex pre-submission agency interactions.

1 Reviews
4,7

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Specificering van de beoordeling
  • Communicatieniveau van de freelancer
    5
  • Kwaliteit van de levering
    5
  • Waarde van de levering
    4
1-1 van 1 reviews
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    4,7

    Excellent work and very knowledgeable, answered several questions I had around some of the regulations that I was not aware of. Will add update to when we import goods and everything goes smoothly with the whole process, but FSVP was written quickly.

    US$ 200-US$ 400

    Prijs

    4 dagen

    Looptijd

    gig

    Bedrijfsregistratie

    Nuttig?
    Ja
    Nee