Monali Patel

Background

About Monali Patel

Qualified & experienced Senior Research scientist (Method development & Validation) with a demonstrated history of over 12+ years of working in the Research & Development centre of pharmaceuticals industry with ADL, QA, QC and RA department. Hands on experience of Analytical method development & Validation; QC testing of various herbal health supplements and nutraceuticals formulation with multi Ingredients multivitamins. Well versed with Pharmaceutics, Regulatory Compliance, lean six sigma concepts, Guidelines like cGMP, GLP, GxP, U.S. Food and Drug Administration (FDA), Health Canada, EMA, MHRA, TGA, ICH & ISO, Analytical Research and Development for products/process development for novel drug products. Expertise with analytical method development & validation of various pharmaceutical dosage form ( Solid orals, liquid orals, Injectables-Simple & Complex, topical) for US, Europe, Canada, Australia, Brazil, South Africa & other ROW markets for Regulatory dossier filing. In depth knowledge of pharmaceutical products and process development, scale up and exhibit batches optimisation based on QbD approach. Sound technical knowledge of Analytical Tech transfer to Plant QC, various regulatory guidelines for successful filing of ANDA, 505b(2) products. Expertise in handling various Sophisticated analytical instruments (HPLC, UPLC, UV, Dissolution, IC, FTIR, LCMS, GC, ICP-AES etc) and software (Empower 3.0, LC Solution, Chromeleon 7.0) SOP, GLP, GDP, GMP, CAPA, OOS/ OOT handling, documentation, data review, technical writing with impeccable organisation and time management skills.