Resources

Why Design Controls Matter for Combination Products Design controls represent one of the most significant regulatory challenges for companies entering the combination product market, especially those with a pharmaceutical or...

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,...