SCx Expert Insights
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
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
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