What is OVI from Quality and Regulatory perspective?
OVI stands for Organic Volatile Impurities which are left over from the manufacture of APIs or drug substances. Residual solvents in drug substances, excipients, and... Read More
Sign In
|Sign Up
Please sign in first
Not a member?
Please simply create an account before buying/booking any courses.
Create an account for free!
Blog
What is IMPD?
In the context of pharmaceuticals and clinical trials IMPD stands for Investigational Medicinal Product Dossier. An IMPD is a comprehensive document that provides detailed information... Read More
What is supplemental new drug application (sNDA)?
From a regulatory perspective, supplemental new drug application is filed to to make changes in a product that already has an approved new drug application. Application... Read More
What is difference between Proof of concept (PoC) Proof of Principle Studies (PoP) in Drug Discovery?
Posted on27 Sep 2023
Comments0
Proof of Concept (PoC) and Proof of Principle Studies (PoP) are both important stages in drug discovery, but they have distinct purposes and differences. The... Read More
Importance of CMC documents?
The CMC information is critical for regulatory authorities to assess the safety, efficacy, and quality of a drug, and to determine whether it meets the... Read More
What is regulatory cmc writing?
Posted on27 Sep 2023
Comments0
Regulatory CMC (Chemistry, Manufacturing, and Controls) writing is a specialized form of technical writing in the pharmaceutical and biotechnology industries. What is CMC means? Chemistry,... Read More
Is Rolling Review and Moving Annual Total are same?
Rolling Review and Moving Annual Total are not the same. In fact they are two different concept altogether. The term “Rolling Review” is not typically... Read More
What is Moving annual total (MAT)? How it is calculated?
The moving annual total is the total value of a variable, such as sales figures for a product, over the course of the previous 12... Read More
How to convert IU to mg?
Here we will be understanding how to convert IU to mg. What formula to be applied for the conversion of IU to mg. You will... Read More
What is Marketing Authorization Application?
Marketing Authorisation Application is an application submitted by a drug manufacturer seeking marketing approval for launch into market. Marketing Authorization Application is the process of... Read More
Market Access meaning in Pharma
In pharma, market access means the the process by which product can be made available to patients and also reimbursed by healthcare systems. The term... Read More
Medical Device Regulation – Assessment Test
Posted on05 May 2023
Comments0
Take a competency test in medical device regulation.