Meranda Parascandola - DSI InPharmatics

January 13, 2026

Published by Meranda Parascandola at January 13, 2026

CMC Readiness for U.S. Expansion: What Foreign CMOs Must Know

For CMOs and CDMOs based outside the United States, serving U.S. clients is a major growth opportunity—but it also comes with heightened scrutiny. U.S. sponsors rely heavily on their manufacturing partners to meet FDA CMC and GMP standards, especially when preparing regulatory filings like INDs, NDAs, and BLAs. If your site or processes fall […]

January 28, 2026

Published by Meranda Parascandola at January 28, 2026

CMO Selection Mistakes Startups Make (and How to Avoid Them)

For virtual biotechs and lean startups, choosing the right Contract Manufacturing Organization (CMO) is one of the most important decisions in early development. The right partner can be the foundation for smooth IND filings, clinical supply readiness, and future commercialization. The wrong one? It can trigger delays, regulatory issues, budget overruns—and even force you to change vendors […]