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Category: Other Blogs

US FDA ANDA

What is the abbreviated new drug application?

By Harry

  04/12/2021

  Category: Other Blogs

An abbreviated new drug application (US FDA ANDA) is a written request an organization sends to the U.S. food and drug administration...

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COVID-19 Consulting

Online consulting services during Covid 19 pandemic

By Harry

  04/05/2021

  Category: Other Blogs

The Covid 19 pandemic changed a lot of things for this generation. During a crisis, people used to stay together to motivate...

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The importance of FDA compliance training for the company

By Harry

  02/13/2021

  Category: Other Blogs

Training is considered an effective tool to improve performance and par excellence. It can help you to systematically have a process in...

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Toxicology consulting Services

Occupational Toxicology: know the importance

By Harry

  02/06/2021

  Category: Other Blogs

Toxicology is a science that aims to understand the interaction and the relationship of chemical agents with the organism under specific conditions...

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Combination drug product development

Combination of Drug Product and Development

By Harry

  01/20/2021

  Category: Other Blogs

BRG recognizes that innovative technologies not often than not have the potential to raise a spectrum of scientific and technical development issues....

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Post marketing Surveillance

An Overview of Post marketing Surveillance of drugs

By Harry

  01/07/2021

  Category: Other Blogs

Summary – post marketing surveillance means that how to monitor drugs in the market once they have been approved and distributed. An...

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COVID-19 Consulting

How COVID-19 Consulting companies deal?

By Harry

  01/02/2021

  Category: Other Blogs

When we talk specifically in terms of organization’s business resiliency, at a great extent it depends on its technologies and systems, and...

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Important Considerations and Benefits of Pre-IND Meeting

By Harry

  12/16/2020

  Category: Other Blogs

After making a lot of plans and strategies, you are ready to start testing your drug in humans, but be confident that...

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Pre- Submission Meeting

Know about the Pre- Submission Meeting

By Harry

  12/11/2020

  Category: Other Blogs

Pre-submission meeting refers to a structured process in order to manage and track interactions between the manufacturer and the FDA regarding future...

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Drug Master File

Know about the types of Drug Master File and its review and benefits

By Harry

  12/06/2020

  Category: Other Blogs

A Drug Master File (DMF) is a document submitted to the FDA that includes a large amount of potentially confidential information about...

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Q Sub Meeting

Types of Q Sub Meeting Submission of FDA

By Harry

  12/04/2020

  Category: Other Blogs

The FDA published the guidance document Medical Device Submission Feedback and Meeting Requests: Q Submission Program in 2019, but it took the...

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FDA De Novo

Know about the FDA De Novo Classification

By Harry

  12/02/2020

  Category: Other Blogs

Recent changes to the Food and Drug Administration Modernization Act of 1997 have made it easier to review and approve new devices....

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