Vishal Mhaske

Medical Writer @Teva Pharmaceuticals

IN

Experienced in preparing Clinical Study Reports (CSR) and regulatory modules in compliance with global regulatory standards. Skilled in handling submissions for USFDA, EU, Health Canada, WHO, ANVISA, NMPA, and ROW markets, ensuring adherence to regulatory requirements.Proficient in eCTD processing, final CSR uploads, system enhancements, and study project management support. Well-versed in fundamental aspects of pharmacology, pharmacokinetics, pharmacodynamics, and statistical concepts. Knowledgeable in ICH-E3, ICH-GCP, E6, ICMR, and bioequivalence guidelines applicable to regulatory documentation.Experienced in literature searches for bioequivalence studies and adept at using regulatory software, including Madra and ISI Toolbox. Familiar with M2 eCTD Electronic Common Technical Document specifications and skilled in quality checks for CSRs and protocols, ensuring precision and compliance.