プロフィール詳細

プロジェクトを作成

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Deepa G.に依頼

Netherlands

Expert in Medical Writing/ Regulatory Affairs consultant

プロフィール概要

➢Medical writing as per new regulation -Clinical (CEP, CER, Literature review, PMS plan etc) & Non-clinical documents (DOC, Risk Analysis, Performance analysis, Usability Eng report, Stability report etc), ➢ Medical devices (General, IVD & Software)/drug product/cosmetics registrations to Asean countries. ➢ MDD/IVDD to MDR/IVDR transition support

専門分野

• ★ Medical Devices

サービス

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Meta-Research, Systematic Literature Review

Data & AI Statistical Analysis

職務経験

Consultant, Regulatory Affairs

Freelancing

1月 2010 - 現在

学歴

Master of Business Information Systems

Madurai Kamaraj University, Madurai, India

1月 2001 - 1月 2005

Bachelor in Pharmacy

Dr. MGR Medical University, Chennai

1月 1997 - 1月 2001

認定資格

• 認定資格の詳細は未入力です。