Pratik Shinde

M. Pharmacy postgraduate with a strong grasp of pharmaceutical development processes critical for CMC documentation.

Experience in rigorous formulation evaluation and analysis ensures an understanding of the data integrity required for regulatory submissions. Knowledge of ISO standards, audit processes and post marketing surveillance. A quick learner with excellent analytical skills seeking an entry-level position in Regulatory Affairs to contribute to the preparation and review of submission documents and ensure regulatory compliance.

Apprentice - MJ BIOPHARMACEUTICAL PVT LTD - Hinjawadi Pune

(2025-06)

Worked as an Apprentice in QA Department at Hinjawadi Pune.

• Conduct in-Process Quality Assurance Checks for Quality Control and ensure timely Corrective Action.
• Review and Approve In-Process and Finished Product ADS
• Review and Approve of Raw Material COA (Certificate of Analysis)
• Handling of LIR, OOS

Industrial Intern - Hindustan Antibiotic Limited - Pimpri Pune

(2022-09 - 2022-09)

One month industrial internship at Hindustan Antibiotic Pimpri Pune.

• Formulation development of various dosage forms in the R&D pilot plant.
• Handling process optimization and scale-up considerations during formulation Development.
• Experience to cross-functional pharmaceutical operations across ADL, Regulatory Affairs, and QA/QC, Stability, and GMP areas.

M. Pharmacy - Pharmaceutics - Sinhgad Technical Education Societies Smt.

Kashibai Navale

College of Pharmacy Pune (2025)

B. Pharmacy - Singad Technical Education Societies Smt Kashibai Navale College of Pharmacy Pune (2023)

HSC - Shri.

Chhatrapati Shivaji

College, Omerga (2019)

SSC - Adarsh Vidyalay, Omerga (2017)