プロフィール詳細

プロジェクトを作成

★★★★★

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Dr. Ratanesh S.に依頼

United States

Nonclinical & ADME Toxicologist | IND‑enabling strategy, mechanistic safety, and high impact scientific writing

プロフィール概要

I accelerate drug and chemical development for biotechs, pharma, startups, and academic labs by designing rigorous studies, interpreting complex data, and delivering regulatory-ready nonclinical packages, manuscripts, and grants—typically within 2–4 weeks for standard deliverables. What I deliver: # ADME & Discovery Toxicology: Study design, dose selection, mechanistic interpretation, risk assessment, and regulatory strategy for small molecules, food additives, agrochemicals, and nutraceuticals. From concept to final technical report in 3–6 weeks. # Regulatory Dossiers: Nonclinical sections for IND/CTA/CTD (IND-enabling) and toxicological risk assessments. Typical timelines: risk summary in 5–7 days; full nonclinical overview in 2–3 weeks. # Scientific Writing: Manuscripts (original and reviews), grant proposals (NIH, DoD, foundation), and responses to reviewer comments. Average: peer-ready manuscript edit in 10–14 days; grant proposal in 2 weeks. Rapid Expert Consults: 60-min troubleshooting calls + written summary for study design, data interpretation, or regulatory strategy—turnaround 24 hours. Deep expertise in: Mechanistic toxicology (in vitro HTS, in vivo models), DILI and hepatotoxicity, genotoxicity (Ames, micronucleus), renal and cardiac toxicity, neurotoxicity, drug–drug interactions (CYP phenotyping, inhibition, induction), immunotoxicology, gut–liver–brain axis, microbiome-linked disease (NAFLD/NASH, obesity, kidney injury, neuroinflammation), and complete ADME (LC–MS/MS bioanalysis, exposure modeling). Track record: # Principal Scientist / Study Director at Eurofins (2022–2025): Led ADME-Tox and safety studies for Discovery and IND submissions; 100% on-time delivery and regulatory compliance. # Research Leader, University of South Carolina (2012–2022): Directed federally funded programs (DoD, VA, NIH); managed CRO partnerships as study sponsor (selection, proposal review, monitoring, audit). Outcome: $5+ million in awarded grants; 40+ peer-reviewed publications (2,050+ citations, h-index 27). # Regulatory Affairs, Sun Pharma (2010–2012): Prepared ANDA/NDA submissions; improved filing turnaround by 20%. Why choose me: Industry GLP discipline + scientific rigor + CRO sponsor oversight = regulatory-ready science delivered fast, without surprises. Editorial board member; grant reviewer (NIH, DoD, Swedish Academy of Sciences). Ready to start? Send a brief project description and timeline—I'll respond with a scope, cost estimate, and plan within 24 hours.

専門分野

• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Omics
• ☆ Transcriptomics
• ☆ PCR
• ☆ Gene Expression Analysis
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytochemistry
• ☆ Cell Signaling Pathways
• ☆ Membrane Biology
• ☆ Neuroscience
• ☆ Molecular Neuroscience
• ☆ Histology
• ☆ Microscopy
• ☆ Light Microscopy
• ☆ Fluorescence Microscopy
• ☆ Data Analysis
• ☆ Image Processing
• ☆ Data Processing
• ☆ Data Visualization
• ☆ Statistics
• ☆ Study Design
• ☆ Environmental Science
• ☆ Environmental Biotechnology
• ☆ Environmental Health
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Blotting
• ☆ Immunohistochemistry
• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ High Content Screening/Imaging
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ Medical Toxicology
• ☆ Occupational Health & Safety
• ☆ Occupational Toxciology
• ☆ Regulatory Affairs
• ☆ Inflammation
• ☆ Research Methodology
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Regulatory Writing
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Medical Writing
• ☆ 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
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Grant Writing

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Technical Writing

Research Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Image Processing, Image Analysis, Data Visualization

職務経験

Principal Scientist & Study Director-II

Eurofins Discovery Services, NA, LLC

8月 2022 - 3月 2025

Research Associate Professor

University of South Carolina

11月 2012 - 8月 2022

REGULATORY SCIENTIST

Sun Pharma (India)

5月 2010 - 11月 2012

学歴

Ph.D. in Biotechnology

Jiwaji University

7月 2006 - 5月 2011

認定資格

• Diplomate of American Board of Toxicology

  American Board of Toxicology

  11月 2025 - 現在