プロフィール詳細

プロジェクトを作成

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Prerana D.に依頼

India

Clinical research professional having an extensive knowledge on medical devices CE marking and consulting services.

プロフィール概要

A clinical research post-graduate having a vast knowledge over a range of Medical devices consulting services on conformation of 62304:2006 standards, regulatory affairs submission documentation and literature search experience for the CE marking of medical devices in comparison to its predicate devices an in compliance to the MEDDEV 2.7.1 rev 4.

専門分野

• ★ Medical Devices
• ★ Regulatory Writing
• ☆ Clinical Trials
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Product Compliance
• ☆ Medical Writing
• ☆ Creative Writing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting, Newswriting

Research User Research, Meta-Research, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Regulatory Consulting

Product Development Concept Development

職務経験

Consultant, Regulatory Affairs

COMMON SENSE SYSTEM INC LIMITED

6月 2021 - 8月 2021

Intern Drug Regulatory Affairs

Dr Reddy's Laboratories Ltd

6月 2021 - 8月 2021

学歴

M.Sc Clinical Research

Jamia Hamdard

7月 2019 - 7月 2021

B.Sc(H) Biomedical Science

University of Delhi

7月 2015 - 7月 2019

認定資格

• NIDA completion- ICH GCP

  NIDA Clinical Trial network

  4月 2018 - 現在