Profile Details

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Hire Navadeep D.

India

USD 100 /hr

Analytical Method Validation & Regulatory Documentation Expert

Profile Summary

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.

Subject Matter Expertise

• ☆ Drug Development
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

Services

• 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)

Work Experience

Specialist

MNC pharma company

October 2022 - Present

Specialist

Dr. Reddy's Laboratories (India)

October 2022 - Present

Education

MPHARAM- PHARMACEUTICAL ANALYSIS & QUALITY ASSURANCE

Andhra university

November 2011 - December 2013

Certifications

• Six Sigma White Belt

  Six Sigma

  January 2026 - January 2026

Publications

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.