Microsoft Office Medical

EDUCATION: Dec, ****

MASTER OF SCIENCE IN REGULATORY AFFAIRS, DRUGS, BIOLOGICS AND MEDICAL DEVICES

NORTHEASTERN UNIVERSITY, Boston, MA GPA: 3.6/4.0

Course work: Introduction to drugs and medical devices, New drug development- A regulatory overview, Human experimentation, Medical device development-A regulatory overview, Biologics development-A regulatory overview, International clinical trials.

BACHELORS OF PHARMACY May, 2015

NIRMALA COLLEGE OF PHARMACY, INDIA GPA:3.7/4.0

Course work: Pharmaceutical Biotechnology, Pharmaceutical Technology, Pharmaceutical Organic Chemistry, Pharmaceutical

Biochemistry, Novel Drug Delivery Systems and Regulatory, Physical Pharmacy, Project Work, Pharmacognosy, Pharmacology, Clinical Pharmacy and Therapeutics, Medicinal Chemistry, Statistical Methods and Computer Applications.

PROFESSIONAL EXPERIENCE

INTERNSHIPS: Apr 2014-May 2014

In-house Research and Development intern, VISHNU CHEMICALS, HYDERABAD, INDIA

Associate member to assist senior scientist in the R&D process.

Analyze the drug samples and develop reports to assess the quality of drugs such as percentage of active ingredient in the sample along with the impurities and adulterants.

Develop reports that were submitted to the clients that own the drug sample and enable drug formulation decision making.

Independently maintained High performance liquid chromatography, gas chromatography, UV spectroscopy, nuclear magnetic resonance, mass spectroscopy.

MAKSON PHARMA, HYDERABAD, INDIA Feb 2015

Check the purity of ointments and creams and reporting the quality of the ointment samples prior to market.

Develop reports for the following tests performed.

Cracking of creams (separation of oil and water)

Change in viscosity

Crystal growth

Microbial contamination (sterility test)

Metal particles in ophthalmic ointments

Dissolution testing of ointments

Determination of granular appearance.

VOLUNTEER EXPERIENCE:

State polio campaign. Govt of Andhra Pradesh, India. Jan 2015

Canvasing to educate rural Indian population on the risk and benefit of receiving the polio vaccine.

Effectively communicated complex product material into lamen technology.

Provided educational ground lectures and polio oral vaccination to uneducated people.

Covered 2 villages per day, able to vaccinate 150 kids in 10 days.

Maintained vaccine integrity by ensuring proper temperature (Maintenance of the “cold chain”- maintaining appropriate temperature from the vaccine manufacturer to the patient).

National Pharmacy week Dec 2014

Translating risk benefit profiles of various medications to non-educated rural Indian population with information regarding drug abuse, adverse events, drug tolerance, drug addiction.

ACADEMIC PROJECTS

FDA regulatory approval to market drug products

Identify the dates of clinical regulatory milestones for product like NDA approval, MOA, Premarket submission, IND and clinical investigational plans of the drug, writing regulatory plan for the drug.

Due diligence

To acquiesce a hypothetical company

Partner in marketing their drug

Submit a new NDA for their product.

Regulatory submission for minor changes in medical devices: Report minor changes that are to be made for the existing device.

Letter to file to FDA

Informed consent: Design a new informed consent for a clinical research

Conflicts of interest: Identify the conflicts of interest that occur in the research, steps to be taken to resolve the issues.

Premarket submission: Submit a new510 k for a device, writing a regulatory document-seeking FDA approval for a new device.

Preparation of Quote for a clinical trial: Preparing a quote for conducting PHASE 1 clinical trial as a CRO

Preparing for an investigator meeting

Preparation for a site initiation visit

SAE reporting

Submission of a BLA

Nirmala College of Pharmacy:

Pharmacognostical, preliminary, phytochemical and pharmacological studies on Bauhinia tomentosa Linn.

screen the pharmacological activity of bauhinia tomentosa Linn’s flower in various concentrations by dissolving in various extracts as Member of 4-person team

Focused on isolating Rat Stomach and measuring effect of active ingredient.

CERTIFICATIONS:

Registered Pharmacist: Pharmacy council of India.

TECHNICAL SKILLS

Operating Systems: Windows, Mac OS X, and Unix/Linux

Tools: Microsoft Office Suite, FOXIT, World PRO

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