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Português
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Michael H
@michael_a122
Medical Regulatory Writer, FDA 510k, CTD Dossier and Clinical Study Reports
Reino Unido
Inglês
Sobre mim
I am a certified Medical Regulatory Writer with 5+ years experience helping pharma, biotech and medical device companies get FDA and EMA approval.
I specialize in:
✓ FDA 510k Submissions
✓ Clinical Study Reports CSR
✓ CTD Dossier Module 2-5
✓ EMA Regulatory Documents
✓ Clinical Evaluation Reports CER
I deliver audit-ready, compliant documents that pass regulatory review on first submission. Worked with 30+ clients globally.
Message me before ordering so we can discuss your project requirements and timeline.
Habilidades
Michael H
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Conheça meus serviços
Redação Técnica
I will write fda 510k submission, clinical study report and regulatory documents
Redação Técnica
I will do medical regulatory writing, ctd dossier, and fda ema compliance documentation
