Resources

Many companies don’t realize they have a combination product until it’s too late. With increased regulatory scrutiny from the FDA, properly identifying your product type is not just important—it’s essential...

503B outsourcing facilities play a critical role in addressing drug shortages and providing large-scale compounded medications. However, with this privilege comes the responsibility of adhering to stringent FDA regulations under...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced it will expand its use of unannounced inspections at foreign manufacturing facilities. This shift is part of the...

FDA inspections are a pivotal moment for any 503B outsourcing facility. Unlike 503A pharmacies, which are primarily state-regulated, 503B facilities are held to Current Good Manufacturing Practices (CGMP) 21 CRF...

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,...