Tirtha Patel Email & Phone Number

Chicago, IL, US

Boston, Massachusetts, United States

• Designed a comprehensive regulatory strategy for the SemPresto epinephrine autoinjector under the FDA’s 505(b)(2) pathway.
• Conducted comparative assessments with predicate devices to establish substantial equivalence.
• Developed a scientific bridge to justify reliance on existing clinical data for epinephrine, focusing on device innovation.
• Prepared critical FDA documentation, including safety, performance, and usability testing outlines, ensuring regulatory compliance.
• Led usability testing to optimize design for emergency use scenarios, enhancing user safety and device reliability.
• Addressed Chemistry, Manufacturing, and Control (CMC) and stability testing requirements to ensure drug-device quality.

Boston, Massachusetts, United States

Vadodara, Gujarat, India

• Prepared and submitted initial registration and renewal dossiers for domestic and international markets, resolving technical issues to ensure compliance and timely approvals.
• Reviewed and maintained critical regulatory documents, including SOPs, BMRs, and BPRs, ensuring timely updates for audits and submissions.
• Monitored regulatory updates and implemented necessary changes in product registration processes to align with evolving guidelines and maintain compliance.
• Assisted in designing new formulations based on customer requirements, considering size, shape, fill weight, color, and master formula, while supporting adherence to regulatory and quality standards.
• Conducted in-process checks during gelatin mass manufacturing and encapsulation processes, ensuring quality and consistency.
• Supervised raw material dispensing activities and assured compliance with formulation preparation protocols

Vadodara, Gujarat, India

• Led a team of four in conducting a dissertation titled 'Study on the Clinical Profile of Patients with Chronic Low Back Pain Attending Neurology Clinic at a Tertiary Care Hospital,' providing evidence-based insights.
• Counseled over 200 patients on medication adherence, lifestyle modifications, and disease management.
• Assisted with ward rounds in Psychiatry, General Medicine, Pediatrics, and ICU, to ensure comprehensive care and patient adherence to prescribed medications.
• Identified and reported adverse drug reactions and drug-drug interactions, enhancing patient safety.
• Collected over 100 patient history and provided guidance on prescribed medication usage.
• Organized and led 3+ awareness camps, educating communities about HIV, STDs, and other communicable diseases, promoting health literacy and preventive care.

Master Of Science - Ms, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Doctor Of Pharmacy - Pharmd, Pharmacy