What is meaning of Common Technical Document (CTD)?
The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines. And it is designed... Read More
What is the difference between Market withdrawal and Product Recall?
Posted on04 Dec 2023
Comments0
Product Recalls are actions taken by a firm to remove a product from the market. by FDA request, or by FDA order,... Read More
What is difference between phase IIa and Phase IIb clinical trial?
Posted on04 Dec 2023
Comments0
Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how... Read More
What is PIC/S? Is India part of PIC/S?
Posted on04 Dec 2023
Comments0
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice... Read More
What is form 356h?
The FDA Form 356h is a specific document used in the United States by pharmaceutical companies and other entities involved in the... Read More
Job descriptions of CMC Writer
CMC Writer’s primary responsibility is to ensures smooth progress of regulatory CMC submissions to health authorities. They involves in regulatory CMC submissions... Read More
Career in CMC Writing
A career in CMC (Chemistry, Manufacturing and Control) writing can be both rewarding and intellectually stimulating. It involves the development and preparation... Read More
Differences between the Laboratory Pilot and Commercial Scale
Posted on17 Oct 2023
Comments0
There are three different types of scale of operation in pharmaceutical manufacturing. Let us explore the differences between each of these scales.... Read More
What is the meaning of scale up in pharma industry?
A Scale-up is an important concept in pharmaceutical and biopharmaceutical manufacturing industry. In the pharma industry, scale up refers to the process... Read More
What is difference between 351(a) vs. 351(k) pathway?
the terms 351(a) pathway and 351(k) pathway are typically associated with the approval of biological products, particularly in the context of the... Read More
