Kevin Modi Email & Phone Number

Brooklyn, New York, United States

Analyzed post-market data from MAUDE, EUDAMED, ECRI, and conducted literature reviews to identify and address potential risks with the VF 1 & VF 3 pro devices.Created and managed comprehensive post-market surveillance plans for the devices, ensuring compliance with EU MDR regulations and internal proceduresPerformed clinical follow-up activities, ensured data accuracy, wrote investigation reports, and facilitated timely resolution of any identified safety concerns.

Vermont, United States

Successfully assisted team members by designing & developing lift assist device, called Refraint for patients in restraints.Led a team of 5 members to determine the classification and approval for a class II active medical device, which involves assessing device risk classification, identifying predicate devices, supporting in 510(k) submissions, and IP searches.Analyzed statistical data, assessed research parameters, and conducted prior art searches of 50 different devices to avoid patent infringement and the device utilized by medical Doctors & health professionals. Learned about the functions of global Health Authorities in the drug development process. Explored how regulatory agencies influence product approvals and safety.

Vadodara, Gujarat, India

•Efficiently screened patients and managed clinical trial data (100% accuracy), reducing study supply costs by 83%.•Supported 32 investigators during regulatory audits, facilitating daily trial activities and ensuring protocol compliance.•Demonstrated reliability with a consistent attendance record and strong communication skills when collaborating with investigators and sponsors.•Working with principal investigator, sub-investigators and sponsor to facilitate clinical research trials and activities and comply with research protocols.•Conducted study visits, informed consent procedures, administered questionnaires, collected medical history, and performed study procedures with a focus on patient safety and advocacy.•Led the implementation and setup of Medidata eTMF, streamlined Trial Master File (TMF) processes, and ensured seamless integration into the organization's workflow through effective collaboration with cross-functional teams.

Vadodara, Gujarat, India

Leveraging innovation to improve patient care :, Focused on providing unique services.Empowering communities through accessible healthcare Fostering culture of wellnessMaintaining FDA guidelines , timely renewal of the license , Profit - loss , expiry returns & Tax filingGenerating bright revenue with getting award in the cityProviding 24 hours service to the patientsMaintaining relationships with suppliers, customers, and local government bodies for smooth functioning of the business

Mehsana, Gujarat, India

Achieved >95% data accuracy in Veeva and implemented a risk management plan for a new product, ensuring its safety. Analyzed QA Standard Operating Procedures (SOPs) and participated in process improvement initiatives.•Performed a wide range of quality control (QC) tests and assays following Good Laboratory Practices (GLPs) on: raw materials, in process materials and final products•Monitored, calibrated, maintained, and evaluated laboratory systems and equipment, including water systems, environmental chambers, and analytical instruments, performed monthly equipment maintenance and cleaning procedures to ensure functionality and accuracy.•Led validation efforts for cleaning procedures, reviewed batch records/protocols, and ensured regulatory compliance.•Contributed to the development of various dosage forms (eyedrops, ear drops, liposomes, tablets, depots) through expertise in injectables and new drug delivery systems.

Performed routine pharmaceutical sample testing and accurately interpreted results; followed protocols for preparation of chemical reagents, media, and solutions. Compiled quality control testing documentation and certificates of analysis for batch record review and demonstrated familiarity with ELISA and cell-based bioassays through academic lab coursework. Expertly maintained and operated lab equipment (biosafety cabinets, pipettes, incubators) while adhering to aseptic techniques for precise microbial sampling and testing.

Ms In Pharmacy Administration , Regulatory Affairs Policy And Health Science

Masters, Ms In Pharmacoeconomics

A

NCC B & C CERTIFICATE

Bachelor'S Undergraduate, Pharmacy

Education record

ACTIVE VOLUNTEER