Phase appropriate development

We support phase-appropriate development efforts that align with both ICH and FDA expectations for early clinical manufacturing. For Phase 1 and 2 trials, we apply GMP principles consistent with FDA guidance (21 CFR Parts 210/211, and “CGMP for Phase 1 Investigational Drugs”) and ICH Q7 and Q8 where applicable. Our approach balances regulatory compliance with development flexibility—ensuring your product is manufactured under fit-for-purpose controls that meet agency expectations while avoiding unnecessary burden. We help you build a foundation that scales efficiently as your program advances.