Resources

Background An established pharmaceutical company with a strong background in biologics and biosimilars was preparing to enter Phase 3 clinical trials with a biosimilar product. While their drug development and...

A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch for an in-depth exploration of PDA/ANSI Standard 06-2025: Assessment of Quality Culture, a...

Combination product submissions require a tailored regulatory strategy that blends device, drug, and biologic requirements. The complexity increases when multiple FDA centers could be involved. The journey begins with identifying...

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...

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...