Twinkle Patel

Detail-oriented and dedicated Pharmacy graduate pursuing a Master's in Regulatory Affairs at Northeastern University. Proven track record as a Regulatory Affairs Intern and Pharmacy Assistant. Known for being proactive, goal-driven, and calm. Eager to contribute to a company's success through collaboration and continuous learning.

• Managed legal cases involving medical device classification errors in the US and EU jurisdictions.
• Demonstrated proficiency in completing FDA forms, including 1572, 2252, and 356h, showcasing a comprehensive understanding of regulatory compliance in clinical research.
• Conducted presentation work on Post-market Risk Management for Cardiac Implantable Electronic Devices, focusing on FDA regulations and guidelines.
• Proficient in accurately completing Investigator Brochure.
• Skilled in navigating and extracting relevant information from clinicaltrials.gov, including ongoing clinical trials and associated documentation.
• Conducted research on regulatory frameworks for nanotechnology-based drugs in the USFDA and EMA, with a focus on substances such as Liposomal Doxorubicin.
• Developed guidelines for effectively addressing a list of questions in the informed consent form related to the upadacitinib for arthritis.
• Submitted Informed Consent Form (ICF) for the VALZ Pilot project, exploring the feasibility and effects on spinal fluid markers in early Alzheimer's disease with Valacyclovir treatment.
• Acquired proficiency in preparing and submitting letters and paperwork to the USFDA, particularly in the context of NDAs.
• Completed a bachelor's thesis on "Hypoxia-Inducible Factor – Prolyl Hydroxylase Inhibitors: Their Role in the Treatment of Various Diseases" for a degree in pharmacy.

• Mentor of Cell and Biologics, Pharmaceutics and Pharmaceutical Calculations in Bachelors of Pharmacy in Nirma University
• Member of Rotaract Club - Nirma University
• Vice President of NIPSA Club - Nirma University