Resources

Explore our extensive resources to uncover more about RCA's expertise in life sciences consulting.

Content Type

Segment

Industries

Blogs

Avoiding Common 503B GMP Deficiencies: Key Lessons from FDA Warning Letters

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...
Read More

Blogs

New FDA Policy Targets Foreign Manufacturers with Unannounced Inspections

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...
Read More

Blogs

Preparing for a successful FDA Inspection as a 503B Facility

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...
Read More

Case Studies

Commercial Readiness Gap Assessment for a Virtual Company

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...
Read More

Case Studies

Remediation & QA System Enhancement

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,...
Read More

Podcasts

Understanding FDA Expectations for Combination Products

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