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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FDA Facility Inspectors and Auditors – An Overview
07/15/2021
Category: Other Blogs
Introduction The Food and Drug Administration is an entity in the United States that is managed and controlled by the United States...
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FDA Fast track designation – An Overview
07/13/2021
Category: Other Blogs
Introduction FDA Fast track is explained as a designation managed by the United States Food and Drug Administrator. They function to approve...
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Abbreviated New Drug Application (ANDA) consulting – A new approach to the generic drug
07/10/2021
Category: Other Blogs
ANDA abbreviated new drug application is a generic drug product that does not require any preclinical (animal) and clinical data. It can...
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FDA Form 483 – Legal acts for food security and cosmetic
07/08/2021
Category: Other Blogs
In every country, there is much company who are producing foods and cosmetics for the public. As these products are for the...
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FDA Experts – Support Drug Anti-Counterfeiting with FDA
07/06/2021
Category: Other Blogs
Manufacturing medical instruments in enormous numbers isn't enough. Pharmaceutical manufacturers are needed to get approvals of FDA Experts compliance so that the...
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Quality Management System in Healthcare
07/02/2021
Category: Other Blogs
The secret of every effective healthcare industry is they cater to provide maximum satisfaction for the care residents. But just proving a...
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FDA Mock Audit: Importance and Necessity
06/20/2021
Category: Other Blogs
Can You Really Trust FDA The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to ascertain a company's compliance...
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Investigational New Drug (IND) Application FDA – Ensuring Safety and Effectiveness
06/18/2021
Category: Other Blogs
FDA's Drug Registration Drug discovery is the process of discovering a new molecule and bringing it to the sector or public. Discovering...
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