Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered from them is accurate, reliable, reproducible, and traceable as well…
NDCT Rules 2019 explained! See how CDSCO’s new drugs and clinical trial regulation 2019 outcomes approvals, compliance, and Novelty. What are the NDCT rules in 2019? Being the second most populous country in the world with skilled labor and good…
Medical device clinical trials & regulations in India India has been a country that the west and the east were keenly looking at for a long time for the conduct of clinical trials. A sleuth of reactive responses to judiciary…
Introduction “Clinical Trial” in regard to a brand new drug or investigational new drug means, any systematic study of such new drug or investigational new drug in human subjects to come up with data for locating or verifying its,-…
– Public Health Emergency The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the healthcare system and broader society, and the impact it may have on clinical trials and subjects. The present situation across…
Background: The new Drugs and Clinical Trial Rules, 2019 have been published with effect from 19th March 2019 with a view to regulate New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability, and ethics committee. The…
Subject: Streaming the Regulatory procedures by Relaxing and Modifying the existing provisions of the Drugs and Cosmetics Rules, 1945 – regarding.
The Central Drugs Standard Control Organization (CDSCO) has told its port offices to stop holding up the importation of medical devices on certain technical grounds. Port officials should now allow the importation of products covered by valid certificates and licenses…
Be the first to know the latest trends in clinical research, real-world case studies, and industry secrets.
ProRelix Research is the rapidly growing Contract/ Clinical Research Organization (CRO) with multi-country service capability supporting phase 1, 2, 3, & 4 clinical trials of Pharma, Biotech, Biopharma, Medical Device, Nutraceutical & Herbal companies to conduct in the USA, India, Europe & South East Asia.