Revathi Tadepalli

• Collaborated with cross-functional teams to ensure successful commercial launch of products
• Reviewed and approved ~200+ GMP controlled documents like specifications, test methods, protocols and reports.
• Demonstrated expertise in regulatory requirements for post-approval changes in pharmaceutical manufacturing.
• Created 300+ regulatory change control records to notify global regulatory authorities.
• Assisted in internal and external regulatory audits for FDA, Turkish Ministry of Health and Tanzania desk audit.
• Manages internal post approval regulatory changes related to API/excipients/packaging components and equipment changes.
• Acts as liaison for commercial manufacturing site and global regulatory strategist team.
• Directs process validations and reviews stability protocols to ensure appropriate stability studies are conducted.
• Managed post approval changes pertaining to Solid Oral Dosage formulations, aseptic and terminally sterilized formulations.
• Prepares USP/EP compendia review for APIs to register in various global markets.

• As Research Scientist, executed the planning and development of analytical test methods and validation in compliance with ICH guidelines.
• Provided analytical support for new drug product development in a Quality by Design (QbD) environment for ANDA submissions, contributing to regulatory compliance.
• Executed testing for API and raw materials, including assay, impurities, dissolutions, and identification, ensuring quality control.
• Developed protocols and conducted peer reviews in accordance with regulatory guidelines and current scientific practices, enhancing compliance and scientific rigor.
• Maintain contemporaneous documentation practices per cGMP using an electronic lab notebook.
• Communications: Communicated both internally and externally in writing and verbally; consulted and negotiated with customers.
• Mentoring: Shared experiences with other scientists to enhance their knowledge and skills.

• Developed stability indicating analytical methods, validated methods, and transferred methods to ensure compliance and reliability.
• Reviewed technical data and prepared detailed protocols and reports to support research objectives.
• Utilized scientific expertise to adhere to regulatory guidelines, ensuring consistent quality and safety in laboratory processes.
• Maintenance and troubleshooting of analytical instrumentation like HPLC, UPLC, UV, IR, KF, pH, Viscometer, AA, ICP etc.
• Gained experience in using Electronic Lab Notebook and laboratory information software systems.
• Exhibited remarkable ability to work in a multi-disciplinary and fast paced environment.
• Maintain contemporaneous documentation practices per cGMP

· Led analysis of drug products, focusing on controlled and delayed release formulations for regulated markets such as the US and Europe under cGLP conditions.

· Performed several pharmacopeial tests, such as Dissolution, Assay, Related Substance (RS), Uniformity of Dosage (UOD) study of Tablets, and Capsules.

· Compiled and mapped dissolution profiles of innovator and in-house products with varying drug-release patterns according to standard test procedures.

· Operated HPLC instruments utilizing multiple detector types, including VWD, MWD, PDA, and fluorescence, ensuring accurate analytical results.

· Performed cleaning validation of production equipment.

Completed training on GLP, GCP, and GMP quality system modules to ensure compliance with industry standards.

• Synthetized and analyzed dye-intermediates, estimated purity, and executed organic reactions including catalyzed processes, functional group transformations, nitration, reduction, and oxidation.