Shreyansh Prajapati
Executive - Regulatory Affairs at Orbit Pharmaceuticals- Claim this Profile
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Bio
Credentials
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Pharma drug regulatory affairs course - DRA 2022
UdemyJun, 2022- Oct, 2024 -
Certificate course on Drug regulatory affairs
Udemy: Online CoursesAug, 2021- Oct, 2024 -
Pharmacist license
Gujarat State Pharmacy Council - IndiaMay, 2023- Oct, 2024 -
Good clinical practice
The National Institute on Drug Abuse (NIDA)Apr, 2021- Oct, 2024
Experience
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Orbit Pharmaceuticals
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India
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Appliances, Electrical, and Electronics Manufacturing
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1 - 100 Employee
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Executive - Regulatory Affairs
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Jul 2022 - Present
Extensive experience in preparation & compilation of CTD dossier, ACTD dossier & Country specific dossiers. Proficient in heading Microsoft word, Excel, Checklist reporting and documentation. Preparation of the dossiers for new registration & re-registration of products to be authorized for ROW market regions. Co-ordinate with other departments such as Production, QA, QC, R & D and Business development team to preparing documents for dossier and managing product samples for submission. Rich experience in various Pharmacological and chemical data from Pharmacopoeias, various websites and Journals for dossier sections and other supportive documents. Review of DMF, AMV, PV, BMR, stability protocol, stability data, Spec, ATP, COA, Artworks (Carton, label, Insert) etc. Show less
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Internship Trainee
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Jul 2021 - Aug 2021
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Training on Computer aided drug design
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Jun 2021 - Jul 2021
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Education
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2018 - 2022
Gujarat Technological University, Ahmedbabd
Bachelor of Pharmacy -B.Pharm, Pharmaceutical Sciences -
Knowledge high school,Nadiad
HSC, science
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