Phase 2: The Prototyping Crucible (Lab-Scale CMC Development)

Service Description

Translates the strategic blueprint into physical laboratory reality under strict GMP-lite controls. Incorporates advanced in-silico modeling, multivariate Design of Experiments (DoE), automated micro-factory synthesis (yielding 32 nm particles with PDI < 0.2), analytical active assay development, and container closure verification. Lead Time: 2 to 4 Months Who is this service for: Scheduled drug formulation (SAHPRA S2–S4), cannabinoid transdermal delivery, veterinary injectables/topicals. What this service adds to your product/offering: Eliminates bioavailability barriers and drug precipitation; establishes reproducible CMC data required for regulatory approval.