Speakers

With a Master’s degree in Organic Chemistry (M.Sc.) from Osmania University, awarded in 2002, and a Bachelor of Science from the same institution in 2000, Apritha brings a wealth of expertise to the field of complex generics projects.

Specializing in intricate generics such as Glatiramer Acetate, Enoxaparin, Liraglutide, Semaglutide, Bivalirudin, Iron Sucrose, Fondaparinux Sodium, and Eribulin, Arpitha has developed extensive knowledge in Quality by Design (QbD), Design of Experiments (DoE), and current GDUFA requirements.

Arpitha is adept at managing regulatory inspections and ensuring compliance, with a proven track record in addressing regulatory deficiencies with accuracy and thoroughness within pre-defined timelines. They possess significant expertise in Chemistry Manufacturing Controls (CMC) and technical writing, including the filing of Drug Master Files (DMF) for complex molecules such as peptides, semisynthetic products, and oligosaccharides.

A strong team leader with a collaborative approach, She excels in organizing and guiding teams effectively. Their in-depth understanding of global regulatory frameworks and compliance requirements, combined with an analytical mindset and results-driven problem-solving skills, allows them to expertly evaluate change proposals and assess their impact on regulatory registrations.

Arpitha is also skilled in new product development and commercialization activities, further showcasing their ability to drive innovation and successfully bring new products to market.