Twinkle Dhruv

Background

About Twinkle Dhruv

With over 5 years of experience in Regulatory Operations, I specialize in publishing and managing submissions across multiple global markets including the US, EU, Canada, Australia, Brazil, UAE, and Switzerland. My expertise spans eCTD, CTD, and baseline submissions, as well as handling initial submissions and ensuring regulatory compliance through robust documentation and process management. I am proficient in tools such as Lorenz DocuBridge, Freyr Submitpro, Lorenz eValidator, Amplexor, LMS, EDMS, and SharePoint, leveraging them to maintain efficient data organization and seamless collaboration. I’m passionate about operational excellence, continuous learning, and contributing to high-quality, compliant submissions that support global product success.