Kishor Kolte

Subject matter expert in Bio analytical studies. Strong business development professional skilled in Good Laboratory Practice (GLP), Liquid Chromatography-Mass Spectrometry (LC-MS), Abbreviated New Drug Application (ANDA), CRO Management Performed a key role from laboratory set up to the audit approval status of Bio analytical laboratory. Performed entire qualification process (URS to PQ) with and without vendor. Laboratory set up and / or transfer. Preparation, review, implementation and compliance of procedural and equipment SOPs. Revision of SOPs as per regulatory guidelines and sponsor requirements as and when required. Method development of small and complex molecules using LC-MS/MS systems within targeted timelines. Method validation as per regulatory requirements as per stipulated timelines. Preparation, review, implementation and compliance of method SOPs, Performed multiple bioequivalence studies involving production of laboratory values within stipulated timelines from study initiation to archival. Performed a detailed review of raw data, adherence to SOP compliance, and regulatory policies. Preparation of laboratory and review of laboratory data for various regulatory audits. Faced and interacted with auditors of various regulatory agencies like USFDA, UKMHRA, EMA and in-house sponsor audits. Present the previous and current data to audit purpose. Response to audit observations during and after the audit. Preparation and review of new SOPs as per current regulatory requirements. A detailed literature search, feasibility studies of molecules as per business plan. Design of method development approach, method development experiments and evaluation of method before its validation as per current regulatory requirements. Design of method validation approach for complex molecules defining acceptance criteria based on current industry trends. Preparation and review of Method validation reports, Bio analytical study reports and compliance with sponsor and regulatory requirements.