Krutik Patel

Experience

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  Department of Science & Technology, Government of Gujarat

  May 2019 - Jul 2019

  Laboratory Analyst

  • Led the intern team and trained them in using instruments like mini lab AAS and flame photometry for the determination of nutrients in the soil.• Worked as a summer internship trainee in the "Soil Health Card" initiative of the government of India.

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  Cadila Pharmaceuticals Limited

  Jan 2021 - Feb 2022

  R&D associate

  R&D (ADL Department)• Demonstrated proficiency in using analytical instruments, like HPLC, GC, and LCMS.• Verified SOPs and other mandatory compliance documents for the US-FDA laboratory

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  GlobalShala

  May 2021 - May 2021

  Entrepreneurship & Innovation Virtual Internship
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  Breegi Scientific, Inc.

  Apr 2023 - Jul 2023

  Regulatory Affairs Associate

  • Prepared and submitted regulatory documents, including protocols, reports, and summary statements, resulting in a 95% approval rate from regulatory authorities.• Conducted extensive market research (CDSCO) and competitor analysis, contributing to an 80% increase in product development efficiency.• Approved and reviewed FDA documentation for IND, NDA, and ANDA with a 90% success rate. • Complied with labelling requirements and enhanced marketing strategies for Medical devices.• Collaborated with cross-functional teams including R&D, Quality Assurance, Legal Affairs and Clinical Research departments to ensure timely completion of submissions Show less

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  Northeastern University

  Sept 2023 - now

  Peer Mentor

  Peer mentor for MS Regulatory Affairs students, Northeastern University Toronto.Sept 2023- Jan 2024

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  Regulatory Affairs Professionals Society (RAPS)

  Oct 2023 - Oct 2023

  Student Ambassador