プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Anurag G.に依頼

India

Pharm.D. Medical Writer & Clinical Researcher | Regulatory Dossiers, High-Impact Manuscripts & Strategic CME

プロフィール概要

In high-stakes clinical and regulatory environments, the quality of your data is irrelevant if your documentation fails to satisfy a Notified Body or a peer-review panel. A single structural oversight in a protocol or a literature review doesn't just invite a "deficiency letter"—it burns through capital and stalls market entry. As a Pharm.D. and independent clinical research consultant, I help pharmaceutical, medical device, and health-tech companies translate complex clinical data into clear, regulatory-ready assets. I specialize in bridging the gap between rigorous science and accessible communication. From Investigational New Drug (IND) applications and Clinical Evaluation Reports (CERs) to peer-reviewed manuscripts and CME materials, I deliver scientifically accurate documentation designed to meet strict regulatory frameworks (FDA/EMA), accelerate time-to-market, and effectively engage key stakeholders. Core Services & Subject Matter Expertise Clinical & Regulatory Documentation: I expertly craft meticulous protocols, Clinical Study Reports (CSRs), and comprehensive literature reviews. My dossiers are built to withstand rigorous regulatory scrutiny, neutralizing technical objections to accelerate market clearance. Scientific Publications & Research: I transform raw data into publication-ready manuscripts, complex case reports, and conference presentations. By ensuring absolute adherence to CONSORT, PRISMA, and STROBE guidelines, I dramatically reduce the "revision-loop" time for high-impact journal acceptance. Medical Education (CME) & Public Health: I leverage clinical insights to build robust needs assessments, high-impact HCP slide decks, and culturally adapted health literacy materials—leveraging real-world experience in running multi-month public health initiatives and infectious disease training. Generic editing is a commodity; clinical accuracy is a strategic asset. Stop risking your research on writers who don't understand the mechanism of action or the regulatory framework behind your product. From generating data-backed manuscripts to developing algorithm-friendly educational materials, I deliver premium, commercially viable clinical content on strict deadlines. Send me your target journal or your regulatory timeline, and I will map out the exact structural framework required to secure your approval today.

専門分野

• ★ Continuing Medical Education (CME)
• ★ Regulatory Writing
• ★ Medical Writing
• ☆ Statistics
• ☆ Health Data Analysis
• ☆ Science Education
• ☆ Biographical Research & Writing
• ☆ SPSS
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ High Content Screening/Imaging
• ☆ Drug Development
• ☆ Preclinical Pharmacology
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Human Biology
• ☆ Preventive Medicine
• ☆ Medical Education
• ☆ Public Health
• ☆ Epidemiology
• ☆ Environmental Epidemiology
• ☆ Rural Development
• ☆ Global Health
• ☆ Disease Control And Prevention
• ☆ Public Health and Sanitation
• ☆ Community Health Services
• ☆ Quality of Life Assessment
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Medical Toxicology
• ☆ Health Informatics
• ☆ Healthcare Administration & Management
• ☆ Medical Billing
• ☆ Medical Affairs
• ☆ Healthcare Quality Improvement
• ☆ Counseling & Mental Health Support
• ☆ Stress Management
• ☆ Bipolar Disorder
• ☆ Psychopharmacology
• ☆ Cognitive Behavioral Therapy
• ☆ Social Medicine
• ☆ Home Health Care
• ☆ Health Risk Assessments
• ☆ Regulatory Affairs
• ☆ Health Education
• ☆ Long-Term Care
• ☆ Rural Health
• ☆ Medical Terminology
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Peer Review
• ☆ Meta-Research
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gray Literature Search
• ☆ Presentation Design
• ☆ Continuing Medical Education (CME) Training
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Content Writing
• ☆ SEO Medical Writing
• ☆ Continuing Medical Education (CME) Materials
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ User Guides & Handbooks
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Course Content 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, Business & Legal Writing, Copywriting, Newswriting, General Proofreading & Editing, Translation

Research Market Research, User Research, Meta-Research, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Regulatory Consulting

Data & AI Statistical Analysis, Algorithm Design-Non ML, Data Visualization, Big Data Analytics, Data Cleaning, Data Processing, Data Insights

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Packaging Design

職務経験

Independent Clinical Research Consultant

Independent Clinical Research Consultant

6月 2023 - 現在

Healthcare and Medical Communications Consultant

Karuna Trust

9月 2025 - 1月 2026

Clinical Pharmacy Researcher & Medical Writer

Avenida Innovations

9月 2024 - 2月 2025

Market researcher and analyst

Nestlé Nutrition

5月 2024 - 7月 2024

学歴

Doctor of Pharmacy (Pharm.D.)

SRI AUROBINDO INSTITUTE OF PHARMACY

7月 2019 - 7月 2025

Doctor of Pharmacy (Pharm.D.) (Pharmacy)

SRI AUROBINDO INSTITUTE OF PHARMACY

6月 2019 - 7月 2025

認定資格

• Understanding Clinical Research: Behind the Statistics

  University of Cape Town

  https://coursera.org/share/1b24f5ea48be29e77b07ce26f212b912

  1月 2026 - 現在

• Business Writing

  University of Colorado Boulder

  https://coursera.org/share/5e04507ad89a68f104779370bff4581f

  1月 2026 - 現在

• Introduction to User Experience Design

  Georgia Institute of technology

  https://coursera.org/share/76abe791815df998bafd0eb36aadda69

  1月 2026 - 現在

• Clinical Trial Analysis & Reporting

  Internshala

  5月 2023 - 5月 2023

出版物

OTHER

Dr. Anurag Gupta (2025). Case Report: Leveraging Jiyyo’s Telemedicine for Early Recognition and Management of Beta-Thalassemia in Rural India . International Journal of Current Pharmaceutical Review and Research 2025.

JOURNAL ARTICLE

Dabhade T, Gupta A, Parashar A, Indhurkhya A. Optimizing Antibiotic and Analgesic Prescribing Patterns in Surgical Care: A Prospective Study on Guideline Adherence. ijnrph [Internet]. 2024 Dec. 31 [cited 2025 Aug. 19];2(2):64-72 .