プロフィール詳細

プロジェクトを作成

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Navadeep D.に依頼

India

Analytical Method Validation & Regulatory Documentation Expert

プロフィール概要

harmaceutical Analytical and QC professional with over 13 years of experience in analytical method validation, method transfer, regulatory documentation, and quality management systems within globally regulated environments. Currently working as a Team Lead and experienced in leading analytical validations for assay, dissolution, related substances, UOD, blend uniformity, water content, and identification tests. Strong expertise in ICH Q2(R1), ANVISA RDC 166, GMP compliance, deviation investigations, and CAPA implementation. Proven experience supporting regulatory and customer audits including MHRA, ANVISA, WHO, CDSCO, EU, Russia, and customer audits. Skilled in preparation and review of method validation protocols and reports, audit responses, deviation investigations, and risk assessments. Available for freelance consulting and documentation support on a part‑time basis, offering practical, audit‑ready, and compliance‑focused solutions to pharma companies, CROs, and consultants.

専門分野

• ☆ Chemical Reagent Development
• ☆ Inorganic Chemistry
• ☆ Analytical Chemistry
• ☆ Spectrophotometry
• ☆ Liquid Chromatography/HPLC
• ☆ Particle Size Distribution
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

サービス

• Writing
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing

Consulting Operations Consulting, Scientific and Technical Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Quality Assurance & Control (QA/QC)

職務経験

Specialist

MNC pharma company

10月 2022 - 現在

Specialist

Dr. Reddy's Laboratories (India)

10月 2022 - 現在

学歴

MPHARAM- PHARMACEUTICAL ANALYSIS & QUALITY ASSURANCE

Andhra university

11月 2011 - 12月 2013

認定資格

• Six Sigma White Belt

  Six Sigma

  1月 2026 - 1月 2026

出版物

JOURNAL ARTICLE

Asha Navadeep Dasari (2013). Spectrophotometric Method Development and Validation for Atazanavir Sulphate and Ritonavir In Bulk and Tablet Dosage form using Absorption Ratio Method . American Journal of PharmTech Research.