by Naveen kumar | 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 Naveen kumar | 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...
by Naveen kumar | Jun 2, 2024
In this article, we are going to see the overview of the Purple Book and its contents, and how it helps healthcare professionals, The FDA Purple Book contains the list of approved biological products, and here we are going to see the details of the Purple book, its...
by Naveen kumar | Jun 2, 2024
How orphan drug designation is given in Japan In the previous articles we have studied orphan drugs and now we are going to learn about how orphan drug designation is given in Japan, we are going to discuss how and what are the laws guiding orphan drug designation in...
by Naveen kumar | May 24, 2024
Standard Operating Procedure for Cleaning of Fluid Bed Dryer Bag 1.0 OBJECTIVE: To lay down the cleaning procedure for the FBD bag 2.0 SCOPE: This SOP shall be applicable for the FBD Bag in the Granulation area in the Production department. 3.0 RESPONSIBILITY: 3.1...
