Swati Pudat

Background

About Swati Pudat

With a strong background in regulatory affairs within the pharmaceutical industry, I am a dedicated and results-driven professional with a passion for ensuring compliance and driving successful product life cycles. Throughout my career, I have developed a comprehensive understanding of CMC dossier compilation and submission for ANDA/ANDS, as well as post-approval submissions for NDA products. My expertise extends to navigating the regulatory landscapes of the USFDA,Canada, EU and International markets allowing me to effectively handle dossier submissions in accordance with the specific requirements of these regulatory bodies. My meticulous attention to detail and keen reviewing skills ensure error-free submissions and high-quality module 3 document reviews. As a Senior Consultant at Continuum India, I have been responsible for a wide range of responsibilities, including authoring CMC sections, conducting due diligence of dossiers, and ensuring GMP documentation and regulatory compliance. I excel in gap analysis, and my analytical document reviews contribute to audit readiness. Previously, as a Senior Executive at Jamp Pharma, I successfully managed Canada ANDS dossier submissions and handled post-approval submissions for the Canadian market. Additionally, my tenure as a Senior Executive at Zydus Group involved supporting US Injectable regulatory submissions, site registration, and responding to deficiencies with precision and efficiency. During my time as an Executive DQA at Micro Labs, I focused on ensuring quality compliance within the R&D department. I am a client-oriented professional with exceptional client handling skills, known for building strong relationships and delivering optimal solutions. My proficiency in stability trending and expertise in QMS make me a reliable partner in product life cycle management. Driven by a continuous pursuit of excellence, I stay updated with the latest regulatory guidelines and industry trends to provide proactive solutions to complex regulatory challenges. With my strong background in commercial compliance and my ability to evaluate change controls related to regulatory submissions, I ensure the seamless alignment of business objectives with regulatory requirements. If you are seeking a regulatory professional with a proven track record of successful submissions, compliance mastery, and an unwavering commitment to quality, I invite you to connect with me. Together, we can navigate the dynamic regulatory landscape and drive the success of your pharmaceutical products.