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Bastien J
@bastienjorahk
Vereinigte Staaten
Englisch, Deutsch
Über mich
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.
Kompetenzen
Bastien J
offline •
Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Compliance & laufende Anforderungen
I will provide fda compliance, fsvp and US agent services
Regulierung für Medizinprodukte
I will prepare your fda 510k premarket submission for medical devices
Arbeitserfahrung
FDA Setup
Feza • Freiberufler
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.
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- Kommunikation
- Qualität der Lieferung
- Preis-Leistungs-Verhältnis der Lieferung
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sebastianelia
Vereinigte Staaten
I’m very happy with the service. The I will provide fda compliance, fsvp and us agent services was handled very well. Great attention to details and a deep understanding of FDA requirements. Everything was explained clearly and the final result was very helpful. I would definitely recommend this freelancer.
Hilfreich?
irongoatprov
Vereinigte Staaten
Laufende Zusammenarbeit
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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