Arpit shah
Deputy General Manager at JAMP Pharma Group- Claim this Profile
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Bio
Experience
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JAMP Pharma Group
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Canada
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Pharmaceutical Manufacturing
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400 - 500 Employee
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Deputy General Manager
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Apr 2022 - Present
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Assistant to General Manager
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Apr 2019 - Apr 2022
• Support the product development team with BA/BE/ Clinical study strategies (Canada, Europe & US).• Determine the best clinical development strategy for a the project to meet the requirements of health authorities and reduce costs.• Select CRO, review study proposals and ensure proper monitoring.• Audit CRO’s for regulatory and GCP/GLP compliance• Evaluate in vitro dissolution profiles and in vitro – in vivo correlation data• Manage the clinical development budget
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Clinical Development Manager
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Apr 2017 - Apr 2022
• Support the product development team with BA/BE/ Clinical study strategies (Canada, Europe & US).• Determine the best clinical development strategy for a the project to meet the requirements of health authorities and reduce costs.• Select CRO, review study proposals and ensure proper monitoring.• Review study reports and provide them in eCTD format for regulatory filing• Audit CRO’s for regulatory and GCP/GLP compliance• Evaluate in vitro dissolution profiles and in vitro – in vivo correlation data• Manage the clinical development budget Show less
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Veeda Clinical Research Limited
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India
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Research Services
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700 & Above Employee
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Sr. Project Manager
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Dec 2007 - Apr 2017
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Education
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2021 - 2022
B.K. School of Professional and Management Studies
PG Diploma in Pharmaceutical Management, Pharmaceutical Marketing and Management -
Gujarat University
M.Pharm., Pharmacology
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