FDA’s Expedited Pathways
05/20/2019
Category: pharmaceutical consulting firms
The ability to bring some drugs to market faster can mean life or death for some patients. The U.S. Food and Drug...
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Reporting Medical Device Adverse Events
05/15/2019
Category: Medical device consulting
Errors associated with medical devices can be costly to health institutions and manufacturers, with some patients paying the ultimate price with their...
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Balancing FDA Compliance in a Pharmaceutical Environment
05/12/2019
Category: Research
Regulatory compliance is a significant topic among quality management personnel. In a pharmaceutical environment, failure to comply with FDA regulations can have...
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Avoiding an FDA 483 at a Pre-Approval Inspection for NDA & ANDA
03/08/2019
Category: Good Industry Practices
Every US FDA ANDA or NDA application requires time and money to develop drugs that will enter the U.S. market. Imagine spending...
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The Significance of Early FDA Interactions
02/15/2019
Category: Good Industry Practices
Pharmaceutical, medical device, and biotech companies have similar road blocks when navigating through FDA’s tough terrain. Regardless of whether a company is...
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Changes to U.S. Drug Labeling – Pregnancy Language Requirements
01/22/2019
Category: Good Industry Practices
The professional prescription drug labeling, such as the prescribing information (PI) or package inserts found in the PDR or at FDA websites,...
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Framework of a Validation Report
12/25/2018
Category: Good Industry Practices
The U.S. FDA is clear that medical devices and/or significant processes must be validated to ensure the standard of quality is being...
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Initial Pediatric Study Plan (iPSP)
12/17/2018
Category: Good Industry Practices
For over 20 years, FDA has promoted the pursuit of increased information and the study of pharmaceutical products in pediatric patients. This...
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Quality Control vs Quality Assurance
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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Epidemiology Topics: Population Dechallenge
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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Pharmacovigilance: What is it?
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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Literature Reviews are Valuable in Regulatory Submissions
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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