12/03/2018
Category: Good Industry Practices
Quality is key to any successful business. Quality ensures standards are being met in processes or products. Companies involved in pharmaceuticals, biologics,...
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11/29/2018
Category: Good Industry Practices
During BRG project meetings, we engage in decision-making as well as philosophical discussions that cross a number of epidemiological topics. These often...
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08/31/2018
Category: Good Industry Practices
Outside the pharmaceutical world, the concept of “Pharmacovigilance” is rarely discussed or understood. In certain circumstances, the full conduct of pharmacovigilance may...
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08/29/2018
Category: Good Industry Practices
A literature review can be used to strengthen a human drug, biologic, or medical device product portfolio and their corresponding regulatory submissions....
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07/29/2018
Category: Regulatory
Establishment Registration and Product Listings Before discussion of the role of the FDA U.S. Agent, it is useful to understand Establishment Registrations...
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