Dhananjay Deshmukh

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.

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.

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)