Nitisha Patel

Currently studying regulatory affairs program at Northeastern University, Toronto campus and looking forward to more opportunities to utilize existing skills and learn new skills as well. More than 3 years of experience in pesticide research and analysis at Navsari Agricultural University, India. Adequate knowledge of ISO/IEC 17025 accreditation and liquid chromatography mass spectrometry (LC-MS/MS) and Gas chromatography (GC). Knowledge of guidelines and regulations about regulatory submission for the US, Canada, and other markets including IND, NDA, and BLA submissions. Full comprehension of FDA, ICH, and CFR standards for drugs, biologics, and medical devices, including GMP, GLP, GCP, IRB, recalls, labeling, packaging, and marketing procedures.

Master of Science with three years of dynamic experience in Analytical Testing, Review and Research
activities. Strong understanding and result interpreting skills for raw material, finished products and retained samples. Adequate knowledge of ISO/IEC 17025 accreditation and liquid chromatography mass spectrometry (LC-MS/MS) and Gas chromatography (GC). Experience of writing research publications.

Currently enrolled in regulatory affairs program at Northeastern University, Toronto. Adequate knowledge of guidelines and regulations about regulatory submission for the US, Canada, and other markets. Understanding of the International Regulations for Product Registration and Approval Submissions, Regulatory Submissions such as IND, NDA, and BLA. Understanding of Quality System Regulations: 21 CFR 820 QSR, CAPA, cGMP, and GLP. Full comprehension of FDA, ICH, and CFR standards for drugs, biologics, and medical devices, including GMP, GLP, GCP, IRB, recalls, labeling, packaging, and marketing procedures. Knowledge in preparing various regulatory documents related to reporting Individual Case Safety Reports for drugs, Mandatory reporting for Medical devices. Knowledge in updating investigators' brochures, and Risk Evaluation and Mitigation Strategies.