Sai Susmitha Challa

Currently conducting a comprehensive regulatory compliance and ethics assessment for AI-driven wellness and emotional health tools, evaluating multiple product features, user experience flows, and data practices against U.S. and international regulatory frameworks including FDA, FTC, GDPR, and EU MDR. The project involves regulatory classification and intended-use analysis to assess medical device, diagnostic, and wellness categorization risk, as well as review of AI governance practices such as training data use, behavioral scoring, user vulnerability, and informed consent mechanisms. Deliverables include regulatory risk matrices, comparative U.S./EU classification analyses, a regulatory roadmap, and recommended claim language, disclaimers, and UX-level consent and transparency text to support compliant product scaling.

Reviewed and approved 100+ GMP-controlled documents, including batch manufacturing records, SOPs, deviations, change controls, and CAPAs, ensuring compliance with 21 CFR and internal quality systems. Supported CMC documentation readiness for formulation development activities by verifying data accuracy, traceability, and compliance, contributing to regulatory submission–aligned documentation packages. Participated in internal audits and inspection readiness activities, assisting in the preparation, review, and timely closure of audit observations, resulting in improved compliance metrics and inspection preparedness. Monitored and supported quality oversight for formulation and development batches, identifying compliance gaps and supporting corrective actions to maintain data integrity and regulatory alignment. Collaborated with cross-functional teams (Formulation, Analytical, Manufacturing) to ensure regulatory-compliant documentation and on-time deliverables across development timelines. Contributed to continuous improvement initiatives by supporting SOP updates and quality process enhancements, improving documentation efficiency and regulatory compliance consistency.

*Supported regulatory submission preparation and lifecycle management activities for IND and NDA applications in accordance with FDA 21 CFR requirements and applicable FDA guidance documents. *Assisted with the review, compilation, and quality control of CMC documentation (eCTD Module 3) to ensure accuracy, consistency, and alignment with regulatory expectations. *Supported clinical trial regulatory compliance by assisting with the preparation, maintenance, and tracking of clinical regulatory documentation in accordance with ICH GCP (E6) and FDA regulations. *Performed regulatory document management and version control, ensuring traceability, data integrity, and submission readiness across regulatory deliverables. *Assisted in the interpretation and application of FDA regulations, guidance documents, and ICH guidelines (Q, E, and M series) to support regulatory strategy and compliance assessments. *Collaborated cross-functionally with Quality, Clinical, and CMC teams to support regulatory alignment, submission timelines, and inspection readiness activities.