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Third Party Blogs

FDA submissions

FDA submissions – FDA Guidelines and catalogue

By Harry

  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

New drug application (NDA) in today’s world

By Harry

  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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Pre IDE

How to know if an IDE is required?

By Harry

  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 consulting

GTP Final Rule for HCT/Ps and its purpose and process

By Harry

  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

IDE Consulting – Innovative and Emerging

By Harry

  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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ectd

An introduction to eCTD and why it is used?

By Harry

  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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FDA citizen petition

Everything About FDA Citizens Petition

By Harry

  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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FDA Combination Products

What are FDA combination products, and why are they important?

By

  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 consulting

PSUR (Periodic Safety Update Report) Consulting services is helpful for you

By Harry

  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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PADER consultant

Future as a PADER (Periodic Adverse Drug Experience Report) consultant

By Harry

  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

Drug Quality Assurance and why it is of utmost importance

By Harry

  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 writing services

Literature Review Services – Become an expert Review Writer

By Harry

  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

FDA Facility Inspectors and Auditors – An Overview

By Harry

  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

FDA Fast track designation – An Overview

By Harry

  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 consulting

Abbreviated New Drug Application (ANDA) consulting – A new approach to the generic drug

By Harry

  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

FDA Form 483 – Legal acts for food security and cosmetic

By Harry

  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

FDA Experts – Support Drug Anti-Counterfeiting with FDA

By Harry

  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

Quality Management System in Healthcare

By Harry

  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

FDA Mock Audit: Importance and Necessity

By Harry

  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 application FDA

Investigational New Drug (IND) Application FDA – Ensuring Safety and Effectiveness

By Harry

  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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