Michael H

@michael_a122

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

United Kingdom

English

About me

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.... Read more

Skills