FDA submissions – FDA Guidelines and catalogue
09/20/2021
Category: Other Blogs
Whenever a new molecule or a generic drug has to be sold in the market, it first needs to be registered with...
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New drug application (NDA) in today’s world
09/16/2021
Category: Other Blogs
In the United States, a board named the Food and Drug Administration, commonly known as FDA, handles the New drug Application (NDA)....
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How to know if an IDE is required?
09/11/2021
Category: Other Blogs
An IDE or Investigational Device Exemption is typically an approval mechanism via FDA to investigate high-risk medical devices. The data you generate...
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GTP Final Rule for HCT/Ps and its purpose and process
09/09/2021
Category: Other Blogs
Those who manufacture human-cell, tissue, and cellular-based products for the FDA have fixed the current good tissue practice. This rule is very...
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IDE Consulting – Innovative and Emerging
08/26/2021
Category: Other Blogs
The computer is an exciting device that can store and process data, sequential arithmetic, and logical operations. But to do all these,...
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An introduction to eCTD and why it is used?
08/23/2021
Category: Other Blogs
eCTD (electronic Common Technical Document) is a great framework for reporting regulatory information to the appropriate health authorities (such as applications, supplements,...
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Everything About FDA Citizens Petition
08/19/2021
Category: Other Blogs
Pharmaceutical companies extensively use the FDA citizen petition to delay the entry of generic drugs into the United States Medicine market. To...
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What are FDA combination products, and why are they important?
08/16/2021
Category: Other Blogs
FDA that is Food and Drug Administration, is a regulatory board that approves drugs and other related items. Therapeutic or diagnostic products...
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PSUR (Periodic Safety Update Report) Consulting services is helpful for you
08/11/2021
Category: Other Blogs
Periodic Safety Update Report, which is generally known as PSUR. It is one of the most important reports which are very much...
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Future as a PADER (Periodic Adverse Drug Experience Report) consultant
08/10/2021
Category: Other Blogs
Periodic Adverse Drug Experience Report, which is popularly known as PADER today, is generally in the hype nowadays. Taking about the PADER,...
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Drug Quality Assurance and why it is of utmost importance
08/01/2021
Category: Other Blogs
In this world of modern medicine, where there is a cure for almost every disease known to mankind, drug quality is needed...
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Literature Review Services – Become an expert Review Writer
07/19/2021
Category: Other Blogs
The literature review is a complex summary of other theories of many highly experienced professionals. In Literature Review Writing Service, the word...
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