プロフィール詳細

プロジェクトを作成

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Rajnandini P.に依頼

India

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

プロフィール概要

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: • NDA/ANDA & 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.

専門分野

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

サービス

• 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

職務経験

Regulatory Affairs Officer

Flamingo Pharmaceuticals Ltd.

4月 2024 - 10月 2025

Research Intern

CliMed Research

6月 2021 - 5月 2022

学歴

M.Pharm.

Shivaji university Kolhapur

12月 2021 - 12月 2023

認定資格

• Research Writing and Publication

  CliMed Research Solution

  5月 2021 - 現在

• Research Methodology & Bioethics Course

  Climed Research Solutions

  5月 2021 - 現在

出版物

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.