Michael H

@michael_a122

Medical Regulatory Writer, FDA 510k, CTD Dossier and Clinical Study Reports

Reino Unido

Inglés

Parte de la información aparece en idioma inglés.

Sobre mí

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.... Lee más

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