Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 25 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Asha J.

India

USD 25 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

Manager

ICON Clinical Research

August 2024 - Present

Study Director

Syngene International

October 2021 - August 2024

Study Director

Bioneeds India Private Limited

July 2020 - August 2021

Senior Research Scientist

Eurofins Advinus Ltd

August 2016 - November 2017

Education

Msc Biochemistry

Muthayammal Arts and Science

May 2007 - May 2009

Certifications

• Msc 4th Rank

  Periyar University

  May 2007 - May 2009