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Background A pharmaceutical company preparing for product commercialization faced significant challenges in meeting FDA expectations. The organization lacked standard operating procedures (SOPs), had minimal supplier qualification controls, and was not...

Background A life sciences company preparing for growth and regulatory scrutiny faced major deficiencies in its quality infrastructure. The organization lacked formal quality systems, had no established Quality Control Unit,...

In this episode of ÐÓ°ÉÂÛ̳ Radio, host Brandon Miller sits down with Jessica Schafersman, a design and development expert at ÐÓ°ÉÂÛ̳®, to break down the increasingly complex world of combination...

The compounding pharmacy industry plays a critical role in modern healthcare by offering personalized medication solutions that mass manufacturers often cannot provide. But with this important role comes a complex...

When a recall occurs the Regulatory Agencies such as the FDA require communication that is timely about corrective actions being taken by companies that FDA may consider have high-risk products....

Ensuring a successful product launch of a connected device requires that your supply chain be capable and available thru the different design and development stages. However, supplier quality management issues...