by Dr. Yashashwini Reddy | 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 Dr. Yashashwini Reddy | 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 Dr. Yashashwini Reddy | 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...
by Dr. Yashashwini Reddy | Jun 4, 2024
In this article, you are going to learn about the regulatory procedure for combination products in the US. What is RFD what are the timelines for it and what role of the Office of Combination products? Combination products as discussed in the article are medicinal...
by Dr. Yashashwini Reddy | Jun 3, 2024
Life Cycle Management of Investigational New Drug Application: Life cycle management of IND applications involves activities that ensure compliance with the regulatory requirements and the safe & smooth running of clinical trials. The important things to consider...
