In FDA-regulated industries, there are a variety of standardized qualifications that a product must meet post-manufacture. In the Life Sciences industry, that means medical devices go through a series of ...
The coronavirus pandemic was a deeply disruptive, global event that sent ripples through just about every industry and occupation. While the Life Science industry has played a central role in ...
Just how connected are quality and the pharma-CMO relationship? As the FDA begins to rein in the regulatory free-for-all that was the COVID-19 emergency use authorization (EUA) process, it ...
The temporary halt of routine onsite FDA inspections in early 2020 forced some drug and device manufacturers into product development limbo, and others had to rethink their strategy for QMS ...
Remote FDA Inspection Audit Maintaining GMP and GCP Inspection Readiness in a Remote-Audit World Medical device, pharmaceutical and life science companies are feeling the impact as the coronavirus pandemic ...
The quality management system (QMS) is the foundation of success for any organization that manufactures regulated products. The quality system reaches departments across the entire product lifecycle, from design and ...
The fields of regulatory science and quality management are constantly changing as industry needs shift and new regulations are enacted to ensure product safety. As new technologies and therapeutic options ...
At Premier FDA Solutions, our business is to help ensure the quality of life-saving and life-enhancing products our clients have developed and/or manufactured, and its availability to patients in need ...
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