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Bastien J
@bastienjorahk
United States
English, German
About me
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.
Skills
Bastien J
Offline •
Average response time: 1 hour
See my services
Business Registration
I will handle fda compliance, fsvp, US agent, 510k dossier, and label review
FDA & Food Safety Clearance
I will register your food facility with fda and set up fsvp compliance
Work experience
FDA Setup
Feza • Freelance
Aug 2024 - May 2025 • 9 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
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irongoatprov
United States
Ongoing collaboration
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.
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