Profile Details

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Hire Rajnandini P.

India

USD 15 /hr

Regulatory Affairs & Clinical Development Consultant | eCTD Expert | BE/IVIVC Specialist | MA Filing

Profile Summary

I have extensive experience in Regulatory Affairs and Clinical Development, specializing in end-to-end regulatory strategy, clinical study planning, and eCTD dossier preparation. I can support your project in: • Regulatory strategy and pathway assessment • eCTD Module preparation and review (2.4, 2.5, 2.6, 2.7, Module 4 & 5) • Clinical study protocol and CSR review • BE/IVIVC study evaluation • Regulatory compliance and deficiency minimization • SmPC/PIL preparation and scientific documentation I focus on high-quality, submission-ready documentation with minimal regulatory queries, ensuring smooth approval timelines. I have worked on: • MA filings and in-licensing submissions • CRO/vendor selection and clinical feasibility • Monitoring BE Studies • Regulatory due diligence and dossier review • End-to-end submission lifecycle support I would be happy to discuss your requirements and provide a tailored solution.

Subject Matter Expertise

• ☆ Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Design
• ☆ Clinical Trials
• ☆ Research Methodology
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ Nonclinical Study Documentation

Services

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting

Research Meta-Research, Feasibility Study, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Business Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Recipe Development

Work Experience

Regulatory Affairs Officer

Flamingo Pharmaceuticals Ltd.

April 2024 - October 2025

Research Intern

CliMed Research

June 2021 - May 2022

Education

M.Pharm.

Shivaji university Kolhapur

December 2021 - December 2023

Certifications

• Research Writing and Publication

  CliMed Research Solution

  May 2021 - Present

• Research Methodology & Bioethics Course

  Climed Research Solutions

  May 2021 - Present

Publications

JOURNAL ARTICLE

Rajnandini Patil (2026). Formulation and optimization of Dryopteris cochleata extract-laden liposomes for immunostimulant activity in rats: in vitro and in vivo evaluation . Drug Development and Industrial Pharmacy.

BOOK CHAPTER

Rajnandini Patil (2024). Advance Drug Delivery Approaches containing Symbiotics . Symbiotic in Human Health: Biology to drug delivery.