プロフィール詳細

プロジェクトを作成

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Veer P.に依頼

India

IVD Regulatory Affairs Expert | Experience in Technical Documentation Writing for IVDR CE Projects

プロフィール概要

A seasoned IVDR Regulatory Affairs Professional with hands-on experience in Technical Documentation (STED/TD) preparation, Technical file preparation which includes GSPR, Scientific Validity Documents, Clinical Performance Documents, Analytical Performance Documents, IFU, Label and Artwork review according to ISO standards for Labeling, etc. With over 2.5 years of experience in the IVD industry, possesses successful track record of preparing more than 150+ technical files for submission of 3 IVDs for CE marking as per IVDR and has 3 IVDR projects completion to his record. Also, experienced in performing gap-analysis of QMS and Documentation System of Company. Possess an education qualification of Masters in Pharmacy (M.Pharm) in Regulatory Affairs which adds value to his credit.

専門分野

• ★ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ★ In vitro Diagnostics
• ★ Regulatory Affairs
• ☆ Microbiology
• ☆ Parasitology
• ☆ Virology
• ☆ Coronaviruses
• ☆ Pharmacy
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ In vitro Diagnostic Validation
• ☆ Point-of-Care Devices
• ☆ Clinical Trials

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Gap Analysis, Systematic Literature Review

Consulting Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC)

職務経験

Senior Regulatory Executive

Avecon Healthcare Pvt. Ltd.

2月 2024 - 現在

Senior Officer - Regulatory Affaris

Meril Diagnostics Pvt. Ltd.

8月 2021 - 1月 2024

Student

Graduate School of Pharmacy, Gujarat Technological University

8月 2019 - 8月 2021

学歴

Master of Pharmacy (M.Pharm) in Pharmaceutical Regulatory Affairs

Gujarat Technological University Ahmedabad - India

8月 2019 - 6月 2021

Bachelor of Pharmacy (B. Pharm) (Faculty of Pharmacy)

Parul Institute of Pharmacy, Parul University

9月 2015 - 5月 2019

認定資格

• In-vitro Diagnostic Medical Device Regulation (IVDR) Training

  TUV SUD

  3月 2024 - 現在

• EU-IVDR 2017/746 Essentials Training

  Comply Guru

  8月 2022 - 現在

• 3-day instructor led training on EU IVDR 2017/746

  Alceon MedTech Consulting

  8月 2022 - 現在

• ISO 13485:2016 - Design and Development of Medical Devices

  udemy

  https://www.udemy.com/certificate/UC-151b4447-c8eb-40cc-8d51-5779797c288a/?utm_source=sendgrid.com&utm_medium=email&utm_campaign=email

  6月 2022 - 現在

出版物

JOURNAL ARTICLE

Veer Jashvantbhai Patel, Manish Mahebub Khetani(2021). A Pharmacognostic review of Liquorice: Pharmacological actions, Current uses and Future prospects . Himalayan Journal of Health Sciences. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 38--45. Society of Pharmaceutical Tecnocrats