Jigar Prajapati

Berufserfahrung von Jigar Prajapati

• Bis heute 1 Jahr und 10 Monate, seit Sep. 2022

  Medical Writer

  Veeda Clinical Research Limited

  • Preparation and review of Clinical Study Report for phases study as per ICH E3 guidance for different regulatory requirements (e.g. USFDA, EMS, NMPA, WHO, Canada, etc.), Protocol, ICFs, etc. with the help of a Medical expert/sponsor medical expert. • Preparation and review of Clinical overview and Non-clinical overview. • Preparation of IB & safety narrative as per sponsors and regulatory guidelines. • Responsible to handle regulatory/Sponsor queries. • POC for clients for projects.