FDA IND CMC Requirements for Biologics: A 2025 Sponsor’s Checklist

The path from a promising biologic drug product to an approved medicine begins long before Phase I Clinical Trials. For drug sponsors, one of the most critical early steps is […]
From API to Clinic: Structuring Your Development Roadmap

The journey from creating an active pharmaceutical ingredient (API) to administering the first human dose is one of the most resource-intensive and strategically critical phases in drug development. While science […]
Why Pharmaceutical Development Services Matter Early in CMC

In the critical and very competitive world of pharmaceutical product development, timing is extremely important. Regulatory deadlines, investor expectations, and market competition create intense pressure on the pharmaceutical sponsors to […]