Profile Details

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Hire Prerana D.

India

USD 10 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

Consultant, Regulatory Affairs

COMMON SENSE SYSTEM INC LIMITED

June 2021 - August 2021

Intern Drug Regulatory Affairs

Dr Reddy's Laboratories Ltd

June 2021 - August 2021

Education

M.Sc Clinical Research

Jamia Hamdard

July 2019 - July 2021

B.Sc(H) Biomedical Science

University of Delhi

July 2015 - July 2019

Certifications

• NIDA completion- ICH GCP

  NIDA Clinical Trial network

  April 2018 - Present