Quality Control Assurance

ANKITH DEVUNAPALLI

********@*****.*** Address: * Cedar Ridge Rd, Green Brook, NJ 08812 Phone: 732-***-****

SUMMARY OF QUALIFICATIONS

• Thorough understanding of submission and review processes including 510(k), PMA, IDE, NDA, BLA, ANDA

• Familiar with FDA and EMA structure, functional organization and relationship with respective industries

• Have sound knowledge in CFR’s, good at regulatory tracking, and accessing regulatory information

• Learned the process of obtaining Orphan Drug Designation and its related submissions to FDA utilizing Form 3671

• Possess a complete understanding and applicability of GXP’s

• Familiar with regulatory overview of special designations like Fast track, HDE, Accelerated & Orphan Drug approval

• Sound knowledge of European Medical Device Regulations, Directives and Guidance’s

RELEVANT EXPERIENCE

Iris Sample Processing, Inc. Westwood, MA

Regulatory Affairs Associate January 2012-Present

• Evaluate and maintain DHF’s, DHR’s, DMF, Validation Reports and Quality Manuals

• Review, Edit and Proofread 510(k) Supplements, Packaging & Labeling materials, Patient Inserts, QA, QC and SOP documents, create hyperlinks, bookmarks along with updating and maintaining data into electronic document system

Aurobindo Pharma Ltd, Hyderabad, India

Regulatory Affairs, Quality Control and Quality Assurance Intern January-June 2009

• Conducted and documented routine analytical testing to check quality of API

• Performed Quality Control tests on finished pharmaceutical product

• Familiarized with ANDA filing to USFDA and Exposed to GMP, GLP and Quality Management Systems

• Gained knowledge in analytical and instrumental problem solving

Jawaharlal Nehru Technological University, Hyderabad, India

Research Assistant, Dr. Sanjay P. Umachigi – Department ofPharmaceutical Sciences August 2009-July 2010

EDUCATION

Northeastern University, Boston, MA March 2012

MS in Regulatory Affairs for Drugs, Biologics and Medical Devices

GPA: 3.8/4.0

Projects:

• Prepared, reviewed and submitted various technical SOP’s, Batch Manufacturing Records, Informed Consent Document, Labels, Audit Check list & Audit Reports, Deviation Forms, and Reply to FDA Warning Letter

• Prepared mock NDA and BLA, Pre IND meeting request, SPA request for Carcinogenicity studies

• Presented and submitted a paper on Biosimilars/Follow on Biologics and FDA Regulations of the Advertising and Promotion of medical products

• Prepared a mock IND and NDA application on a Fictitious drug CARDIPROL in the CTD format

• Developed and submitted a regulatory(submission) plan for a

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