by Naveen kumar | Jun 10, 2024
Clinical trials are research studies involving human subjects to know the safety, and effectiveness of medical interventions such as drugs, medical devices, biological products, and radiological procedures. People generally volunteer to take part in these studies and...
by Naveen kumar | Jun 8, 2024
A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...
by Naveen kumar | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
by Naveen kumar | Jun 5, 2024
Clinical Trail Registration Process In the US In the US clinical trials are registered in clinical trial.gov which is a publicly available database, this is an online database managed by the National Library of Medicine (NLM), In this database we can get information...
by Naveen kumar | Jun 4, 2024
Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...
