Nikita K. Patel

- Lead regulatory compliance for multi-site clinical research studies, ensuring adherence to FDA and ICH-GCP standards. - Manage end-to-end study start-up and maintenance, including IRB submissions, continuing reviews, amendments, consent updates, and regulatory correspondence. - Maintain accurate and up-to-date regulatory binders and essential documents, supporting inspection readiness and lifecycle study maintenance. - Cross-functional coordination with investigators, finance team, IRB, sponsors, CROs, and research operations teams. - Assist with quality assurance activities, including internal audits, regulatory inspections, and trial close-out processes. - Support process improvement and system optimization initiatives, including implementation of the Florence eRegulatory system through regulatory document migration, workflow standardization, and improved inspection readiness.

- Reviewed study protocols, analytical methods, validation reports, batch records, raw data, and final study reports to confirm accuracy, completeness, reliability, and regulatory compliance. - Conducted internal audits of bioanalytical studies, including LC-MS/MS assays, to ensure compliance with FDA regulations, GLP (21 CFR Part 58), ICH, ISO, and applicable regulatory guidelines. - Collaborated with laboratory management and study teams to review audit findings, implement and track CAPA, and ensure timely resolution of compliance gaps. - Identified, escalated, and supported investigation of data discrepancies, deviations, and laboratory errors, contributing to timely resolution and corrective actions. - Verified data integrity, traceability, and transparency in accordance with regulatory expectations and quality system requirements.

- Assessed laboratory procedures, documentation practices, and equipment calibration and maintenance records for regulatory compliance. - Supported quality system improvements, SOP development, and ongoing FDA inspection readiness. - Identified recurring documentation gaps and recommended process improvements, including support for SOP, form, and template revisions to enhance clarity and compliance. - Evaluated laboratory procedures, documentation practices, and records—including equipment calibration, validation, and maintenance—for alignment with regulatory and industry standards.

- Established the hydrophobic and intermolecular H-bond residues involved with the binding of inhibitor ligand and the enzyme binding pocket - Executed and completed a literature review on the use of phytopharmaceuticals in the aldose reductase inhibitors field and molecular docking. - Validated the neem plant compounds into the binding pocket of aldose reductase by analyzing the 3-D crystal structure of hydrophobic and intermolecular H-bond residues in the enzyme binding pocket - Created a protocol using ArgusLab for molecular docking of a new compound into the enzyme binding pocket

- Gained the technical knowledge and skills required to enable stakeholders to navigate an increasingly complex global regulatory environment. - Enhanced my understanding of the laws and standards that govern the development, manufacturing, and commercial distribution of medical and biomedical products. - Learned to analyze how emerging developments and trends are reshaping global biomedical product commercialization regulations. - Learned to study the regulations applicable to biomedical product commercialization from pre-clinical development, quality, and manufacturing perspectives. Courses: Regulatory Strategy for Product Development Human Experimentation Therapeutic Product Development Legal Issues in International Regulations Global Impact of eCTD Regulatory Affairs Strategic Project Management Advanced Regulatory Writing Biomedical Product Development Practical Applications in Global Regulatory Affairs

Major: Biotechnology & Minor: Biochemistry at School of Environmental and Biological Sciences (SEBS) Student of Douglass Residential College (Women's College) Courses: Nucleotide Sequence Analysis Basic Statistics for Research Concepts & Issues in Biotechnology Methods & Applications in Molecular Biology Molecular Genetics Biochemistry of Cancer Tools for Bioinformatic Analysis Introduction to Computer Science Data Structures