Pratik Shewale

M.Pharm in Pharmaceutical Chemistry with 2 years experience in API analytical development and formulation testing at Acme Life Tech LLP and Kopran Research Laboratories. Skilled in HPLC, GC, Karl Fischer titration, dissolution profiling, impurity analysis, and stability studies, ensuring ICH, GMP, and ALCOA+ compliance while supporting regulatory submissions, batch release, and pharmaceutical R&D.

Officer – Analytical Development Laboratory (Formulation) at Acme Life tech LLP

• Led formulation testing for solid oral dosage forms, including assay, dissolution profiling, and content uniformity across multiple projects.
• Executed analytical method validation in strict compliance with ICH Q2(R1) standards, ensuring technical accuracy and regulatory readiness.
• Performed stability sample testing while maintaining GMP-compliant documentation and adherence to ALCOA+ data integrity principles.
• Optimized testing workflows to improve efficiency and reduce turnaround time for regulatory submissions.
• Troubleshoot analytical instruments to ensure uninterrupted workflows and accurate data reporting.
• Maintained strict adherence to ICH guidelines, method validation protocols, and GMP standards.

Officer – Analytical Development Laboratory (API) at Kopran Research Laboratories Limited

• Executed HPLC and GC analyses for raw material assays, impurity profiling, and organic purity testing of APIs.
• Conducted Karl Fischer moisture determinations and pH calibrations to support routine batch release compliance.

Master of Pharmacy (M.Pharm) in Pharmaceutical Chemistry – MGV's Pharmacy College, Nashik (2023)

Bachelor of Pharmacy (B.Pharm) – Ln Dr. JD Pawar College of Pharmacy, Kalwan, Nashik (2020)