Senior Compliance Manager,
Quality & Regulatory Affairs
Ms. Kallam provides Quality and Regulatory compliance oversight at Saptalis to assure that all manufacturing, testing and product development activities are conducted as per USFDA regulations. She establishes compliance procedures and develops strategies to ensure the Company complies with all federal, state, and local regulations, including cGMP, cGLP, USP, ICH and USFDA guidelines.
Ms. Kallam provides CMC strategic guidance for submission of ANDA/NDA filings to the FDA to assure their high quality and timely approval. Proficient with use of software tools such as eCTD and SPL Editor for submission of regulatory filings to the USFDA.
Ms. Kallam holds a B.Pharm. degree from Jawaharlal Nehru Technological University, Hyderabad, and M.Pharm. degree in Pharmaceutical Technology from Andhra University, Vishakhapatnam, India.