Samskruthi M.D.

Regulatory Affairs Associate @BPI Labs, LLC

Brookline, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2023 — Present

Regulatory Affairs Associate @BPI Labs, LLC

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US

EDUCATION

2021 — 2022

Northeastern University

Master's degree

ABOUT SAMSKRUTHI M.D.

I Samskruthi Mamidi,graduate student pursuing Masters in Regulatory Affairs in Northeastern University.I am enthusiastic and hardworking student looking forward to create a aspiring position in Regulatory Affairs field.I hold a Bachelor degree in the field of a Bachelor of Medicine and Bachelor of Surgery(MBBS)which is equivalent to MD in USA.My academics covered important aspects in the fields of pharmacology,Surgery,Internal Medicine,Anatomy and public health which helped me to create a meaningful impact in the fields of health care providing.I am a licensed physician with a experience of 2years working in various Medical offices in both private and government sectors.I choose to pursue Masters in Regulatory Affairs from Northeastern,an impactful course which has a huge role in practical implications for public health.With this degree and training i got exposure to various aspects of Regulatory Competencies related to Drugs,biologics and Medical Devices.Have good knowledge on US,European and other global Regulatory Frame works used for the Drugs,Medical Devices and Biologics.I am good at IND,NDA,ANDA,PMA,510(K),De-Novo,IDE and other Regulatory submissions.And sound knowledge on Research and Development,GLP,GMP,GCP,ICH, and IRB Guidelines. And also thorough with MDD,EU MDR,IVD and QSR.And also well trained in Informed consent forms,DSUR and knowledge in Investigational brochure,Protocols and Clinical trials applications along with research Methodology.Feel free to connect and providing me opportunity to work.

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