Pratik Shewale

M. Pharm (Pharmaceutical Chemistry) professional with over 2 years of industrial ADL experience specializing in API analysis, impurity profiling, and forced degradation studies. Expert in stability-indicating method development, validation (ICH Q2), and analytical troubleshooting utilizing HPLC/GC (Empower 3/LabSolutions). Proven track record in cGMP environments with strict adherence to ALCOA+ data integrity principles.

Officer - ADL(Formulation) at ACME LIFETECH PVT LTD (2025-12 – Present)

• Formulation analysis of solid oral dosage forms (assay, dissolution, related substances, content.uniformity).
• Analytical method development and validation as per ICH Q2(R1).
• Stability sample analysis with GMP-compliant ALCOA+ documentation.

Officer - ADL(API) at KOPRAN RESEARCH LABORATORIES LIMITED (2024-07 – 2025-12)

• HPLC/GC analysis for assay, purity, and impurity profiling of APIs.
• Karl Fischer moisture analysis, pH testing, and analytical troubleshooting.
• GMP-compliant data recording and documentation.

Master of Pharmacy in Pharmaceutical Chemistry – MGV's Pharmacy College, Panchavati

Bachelor of Pharmacy – Ln Dr J D Pawar, College of Pharmacy