by Dr. Yashashwini Reddy | Jun 30, 2025
⚖️ Clinical Investigations Compliance & Enforcement in Clinical Research 🔍 1. What is Clinical Investigations Compliance? Clinical investigations compliance refers to the adherence to ethical, regulatory, and scientific standards during the planning, conduct,...
by Dr. Yashashwini Reddy | Jun 30, 2025
📘 Regulations: Good Clinical Practice (GCP) and Clinical Trials Good Clinical Practice (GCP) is an international ethical and scientific standard for designing, conducting, monitoring, recording, auditing, analyzing, and reporting clinical trials that involve human...
by Dr. Yashashwini Reddy | Jun 15, 2024
Navigating the Premarket Notification (510(k)) Process Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical...
