プロフィール詳細

プロジェクトを作成

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Dr. Sumit M.に依頼

India

Physician & Regulatory Consultant | Medical Writer | Clinical Trial Design & CSRs | WHO, NIH & Stanford Certified

プロフィール概要

I am a medical doctor (MBBS) and certified clinical researcher specialized in high-stakes regulatory documentation and clinical trial design. My expertise bridges the gap between clinical medicine and stringent regulatory requirements (ICH-GCP). With advanced certifications from the NIH in Clinical Pharmacology, Bioethics, and IPPCR, and Stanford in Scientific Writing, I provide high-precision authoring for: | Regulatory Docs: CSRs, IBs, and Protocols (ICH E3/E6). | MedTech Compliance: EU MDR Clinical Evaluation Reports (CER). | Clinical Research: Trial design and pharmacological consulting. I ensure every document is audit-ready, scientifically robust, and strategically aligned with FDA/EMA

専門分野

• ★ Regulatory Writing
• ★ Clinical Study Reports
• ★ Technical & Scientific Writing
• ☆ Drug Development
• ☆ Preclinical Pharmacology
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ SOP & Protocol Writing
• ☆ Grant Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing, Translation

Research Market Research, User Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Big Data Analytics, Data Cleaning, Data Processing, Data Insights

Product Development Product Validation, Quality Assurance & Control (QA/QC), Prototyping

職務経験

Medical intern

NIMS University Rajasthan, Jaipur

3月 2025 - 3月 2026

学歴

MBBS

NIMS University Rajasthan, Jaipur

3月 2020 - 3月 2025

認定資格

• Stanford: Writing in the Sciences

  Stanford

  https://www.coursera.org/account/accomplishments/verify/7FNVUEPEAJ9I

  4月 2026 - 現在

• Good Practices for Clinical Trial Design and Implementation

  World Health Organization

  https://whoacademy.org/achievements/ef67c905-f50e-419a-85e1-4c0bc13da037

  5月 2026 - 12月 2026

• ICH GCP E6 (R3)

  The Global Health Network

  5月 2026 - 12月 2026

• Principles of Clinical Pharmacology

  National Institutes of Health

  4月 2026 - 12月 2026

• Introduction to the Principles and Practice of Clinical Research

  National Institutes of Health

  4月 2026 - 12月 2026

• Ethical and Regulatory Aspects of Clinical Research

  National Institutes of Health

  4月 2026 - 12月 2026

出版物

JOURNAL ARTICLE

S. . Mahajan, “Awareness Regarding Hand Hygiene among Medical and Nursing Students and Paramedical Healthcare Staff of Tertiary Care Hospitals”, J Neonatal Surg, vol. 14, no. 4, pp. 548–551, Aug. 2025 .