プロフィール詳細

プロジェクトを作成

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Dr. Asha J.に依頼

India

Bioanalytical Scientist | PK/PD & Immunogenicity Specialist | Biologics, Biosimilars, ELISA & Clinical Research Expert

プロフィール概要

I am a Regulatory & Bioanalytical Scientist with over 12 years of experience in PK/PD studies, Immunogenicity (ELISA, MSD, ADA, NAb assays), and Regulatory Affairs for Biologics and Biosimilars. Skilled in ligand binding assays (LBA), method development, validation, and regulatory documentation (CTD/eCTD, CMC, IND/BLA submissions). I have worked extensively in clinical & preclinical studies, pharmacokinetics, pharmacodynamics, and bioanalytical strategy for global submissions. I provide freelance support in regulatory writing, medical writing, assay validation, PK/PD data review, and biosimilar regulatory compliance for clients worldwide.

専門分野

• ★ Preclinical ADME/PK/PD
• ★ Clinical Trials
• ★ Clinical Biochemistry
• ☆ Biochemistry
• ☆ Drug Development
• ☆ Bioanalytical Testing
• ☆ Preclinical Research
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Laboratory Science
• ☆ Regulatory Affairs

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Scientific and Technical Research

Consulting Scientific and Technical Consulting

Data & AI Data Processing

職務経験

Manager

ICON Clinical Research

8月 2024 - 現在

Study Director

Syngene International

10月 2021 - 8月 2024

Study Director

Bioneeds India Private Limited

7月 2020 - 8月 2021

Senior Research Scientist

Eurofins Advinus Ltd

8月 2016 - 11月 2017

学歴

Msc Biochemistry

Muthayammal Arts and Science

5月 2007 - 5月 2009

認定資格

• Msc 4th Rank

  Periyar University

  5月 2007 - 5月 2009