Soujanya Madasthu

Team Lead @Freyr Solutions

Hyderabad, IN

Global Regulatory SubmissionsProvide regulatory inputs to global program strategy including submission to the Health Agencies Delivered regulatory expertise to cross‑functional teams, guiding development of protocols, IBs, DSURs, PSURs, and Annual Reports.Proven ability to lead diverse teams, fostering collaboration and driving successful regulatory outcomes.Recognized subject matter expert in regulatory submissions for medical devices, including 510(k).Specialized expertise in interpreting and applying US FDA regulatory requirements.Skilled in optimizing and upgrading document management systems to enhance efficiency and compliance.Experienced in client meetings, providing regulatory insights, and ensuring alignment with project goals.

CMR College of pharmacy

Bachelor's degree

Sri Chaitanya College of Education

Intermediate Board

Malla Reddy College of Pharmacy (MRCP), Secunderabad

Master's degree