Prathibha Gowda
Drug Regulatory Affairs- Lead Consultant at Genpact
Based in Bengaluru, India
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Seniority
Manager
Department
Science
Location
Bengaluru
Industry
Business Consulting and Services
Company size
139K
Contact information
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p•••••••@genpact.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Prathibha Gowda
Currently serving as a RA Lead Consultant at Genpact, specialized in drug regulatory affairs and quality/regulatory compliance with over 14 years of experience in the pharmaceutical industry. Proficient in US FDA filings, including ANDA submissions, amendments and supplements with a focus on injectables and solid oral dosage forms. Skilled in CMC Review, authoring and eCTD filing (publishing) and implementing Quality systems (Quality by Design principles in R&D environments). Contributed to regulatory information management system (RIMS) data enrichment and migration to Veeva Vault, ensuring seamless data accuracy and quality control. used various sources like SPOR and XEVMPD databases, data analytics for data enrichment & migration. Dedicated to advancing regulatory processes through meticulous data analysis, using data analytics, project management skills. Motivated by a strong commitment to compliance, attention to detail in regulatory filings.
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