Saannya Sequeira
Regulatory Medical Writing Consultant at Wealthy Technology
Based in Paris, France
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Seniority
Staff
Department
Other
Location
Paris
Industry
Software Development
Company size
6
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s•••••••@wealthy-technology.com
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Background
About Saannya Sequeira
Freelance Medical Writer with over 7 years of experience in regulatory medical writing for medical devices, drug products, and biologics (EU MDR, EMA, FDA). Expert preparation of these common clinical and regulatory documents- Clinical Protocols - Clinical Study Reports - Investigator's Brochures - Patient Information Sheets and Informed Consent Forms - Clinical Summaries: CTD sections 2.5, 2.7.3, 2.7.4, Integrated Summary of Safety, Integrated Summary of Efficacy - Safety Narratives - Clinical Investigation Plans (MDR)- Clinical Evaluation Plans (MDR)- Clinical Investigation Reports (MDR)- Clinical Evaluation Reports (MDR)- Post-Market Clinical Follow-up Plans and Evaluation Reports (MDR)- Post-Market Surveillance Plans (PMS)- Statistical Analysis Plans - Systematic Literature Reviews - Publication plan management - Journal Articles (Original research papers, case reports, letters, communications etc.)- Posters and Oral Presentations - Medical and Scientific Translations (English-French).
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