Skip to main content
Dhananjay Deshmukh

Dhananjay Deshmukh

M.Pharm. (Pharmaceutics) | Research Associate

Talent
AhmedabadMember since May 18, 2026
CTD/eCTD Dossier PreparationICH M4 GuidelinesXML/SPL ValidationLifecycle ManagementSOPFormulation DevelopmentQuality by Design (QbD)Technical Documentation
·

Hire this person

Send a job offer directly to this candidate

CTD/eCTD Dossier PreparationICH M4 GuidelinesXML/SPL ValidationLifecycle ManagementSOP

About

GLP-compliant M.Pharm. (Pharmaceutics) professional with CRO experience in technical documentation, regulatory compliance, formulation development, and pre-clinical toxicological research. Proven expertise in CTD/eCTD dossier preparation (Modules 1–5) across USFDA, EMA, and ICH frameworks. Consistent record of zero data integrity findings in audits, with the cross-functional discipline to deliver compliant, on-time outcomes across Research, QAU, and Regulatory functions.

Experience

Research Associate at Aragen Life Sciences (2024-11 – 2026-01)

  • Supported the Head of Study (HOS) in departmental operations including report preparation, data collection and compilation, formulation preparation, and QA data verification — adhering to study-specific SOPs with zero protocol deviations.
  • Executed 6–10 GLP-compliant toxicological studies evaluating the safety, efficacy, and pharmacokinetic profiles of pharmaceutical compounds, delivering on-time results across all study phases.
  • Contributed to 1 NGCMA regulatory audit, achieving zero data integrity findings through robust documentation practices and audit-ready laboratory records.
  • Coordinated with a 10+ member cross-functional team across Research and QAU, driving 100% protocol adherence and consistent on-time study delivery across all assigned projects.
  • Completed on-site GLP certification training, strengthening competency in regulatory frameworks, quality systems, and pharmaceutical R&D compliance standards.

Education

Master of Pharmacy (M.Pharm.) in Pharmaceutics – Manipal College of Pharmaceutical Sciences (2022 – 2024)

Bachelor of Pharmacy (B.Pharm.) – GES's M. S. Gosavi College of Pharmaceutical Education & Research (2018 – 2022)

Skills

M.Pharm. (Pharmaceutics)Research Associate

Reviews