09/21/2020
Category: Other Blogs
Every company nowadays uses different consulting services. The marketplace provides several consultancy services. Customers and companies are gradually choosing sustainable and environmentally...
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09/18/2020
Category: Other Blogs
FDA stands for the Food and Drug Administration, a government agency responsible for food safety, dietary supplements, human drugs, vaccines, blood products...
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09/13/2020
Category: Other Blogs
If you're wondering if an external enforcement company needs to be engaged, consider the following benefits an experienced consultant may offer: Quick...
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08/09/2020
Category: Other Blogs
Many companies are utilizing emergency use authorization, or EUA, to get medical products to FDA for the U.S. marketplace. It is a...
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07/16/2020
Category: Other Blogs
Biotechnology and pharmaceuticals are both technologies used in develop medical treatments. Often a biotechnology company uses living organisms/cells for the development of...
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07/06/2020
Category: Other Blogs
U.S. food and drug labeling are to be compliant with the rules and guidelines of the Food and Drug Administration (FDA). FDA...
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06/15/2020
Category: Other Blogs
Day-by-day new insights into diseases are made. New drugs, devices, biologics and new uses for old products are introduced to the marketplace...
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06/09/2020
Category: Other Blogs
FDA consultants, like Biotech Research Group, can provide support and regulatory submissions for FDA fast track service. FDA Fast Track is a...
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06/04/2020
Category: Other Blogs
SARS-CoV-2 leading to the coronavirus-associated disease, COVID-19, is highly contagious. The aerosolized transmission explains the speed with which it has spread around...
Read More05/26/2020
Category: Other Blogs
Coronaviruses are a family of viruses that can be pathogenic for humans and animals. In humans, several coronaviruses are known to cause...
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05/19/2020
Category: Other Blogs
Medical devices are essential tools for human medicine. They are intended, by their manufacturer, to be used with medical advice/administration and provide...
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05/12/2020
Category: Other Blogs
This is a question that many of us, as patients or family members of people with rare diseases in particular, ask ourselves....
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05/07/2020
Category: Other Blogs
The techniques and methods used in device evaluations depend on the type of specific product. Devices are diverse in nature in components...
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05/02/2020
Category: Other Blogs
During the development of a new drug, a sponsor should determine whether the product is safe for early use in humans and...
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04/22/2020
Category: Other Blogs
Creating and producing biopharmaceuticals is expensive and difficult. As products move into the global maze of differing and sometimes changing government regulations,...
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04/14/2020
Category: Other Blogs
Regulatory affairs services are used to comply with protecting public health, and they can contribute to the safety and efficacy of medical-related...
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04/10/2020
Category: Other Blogs
Quality assurance services include identifying quality metrics, ensuring continuous improvements, and aligning with your business needs and objectives. Medical device subsystem consultants...
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04/02/2020
Category: Other Blogs
Since 2006, there has been a labeling redesign from the past FDA drug labeling program. Drug labeling is now presented as a...
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02/26/2020
Category: Other Blogs
In general, the 510 k premarket notification for devices in the U.S. marketplace are clearances by FDA as findings of substantial equivalence...
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02/20/2020
Category: Other Blogs
Companies should choose pharmaceutical consulting that allows for special attention to unique differences to position a product at the lowest cost to...
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