Professional Background

At ClinRM, Sravya serves as Regulatory & Drug Safety Specialist and Project Manager, coordinating cross-functional teams to establish project timelines, deliverables, and compliance processes. She has developed internal documentation systems and quality control frameworks to prepare for future clinical and regulatory submissions. Previously, as a Regulatory & Clinical Research Intern at XN Capstone Project, she designed clinical validation study protocols for digital therapeutics aligned with FDA, IRB, and IDE requirements, and contributed to patient recruitment strategies and submission-ready documents. Her clinical foundation includes a year as Clinical Pharmacist Intern at Durga Bhai Deshmukh Multispecialty Hospital in India, where she conducted medication therapy management, adverse drug reaction minimization, and prescription reviews while collaborating with physicians to optimize patient regimens.

Core Expertise

• Regulatory compliance: FDA submissions, IND strategy, IRB protocols, eCTD formatting.
• Pharmacovigilance: Safety reporting, SAE processing, signal detection support, PV SOP development.
• Clinical research: Protocol development, study coordination, patient recruitment, data analysis.
• Project management: Cross-functional coordination, timeline management, documentation systems.

Career Highlights

• Managing regulatory-compliant content development and quality systems for ClinRM's clinical and regulatory pipeline preparation.
• Designed FDA/IRB-aligned clinical validation study protocols for digital therapeutics, including patient recruitment strategies and submission-ready documentation.
• Led comparative clinical research study on antibiotic efficacy, coordinating patient recruitment, data management, statistical analysis, and peer-reviewed publication.
• Conducted medication therapy management and adverse drug reaction minimization during clinical pharmacy internship, optimizing regimens through physician collaboration.

Certifications

• Regulatory Affairs Certification (RAC — Drugs), RAPS (2025–2028)
• Good Clinical Practice (GCP) Certification (2024–2027)

Education & Clinical Training

• Master of Science in Regulatory Affairs — Northeastern University, Boston, MA (July 2025)
• Doctor of Pharmacy (PharmD) — Bharat School of Pharmacy, Hyderabad, India (July 2023)

Therapeutic Focus