Drug development is costly and unpredictable, and value is often lost late, after major CMC and manufacturing investments are committed. Pharmatech Associates, a USP company, applies FDA aligned in silico CMC modeling to make development more predictable by de risking tech transfer and scale up, strengthening control strategies, and accelerating stability and shelf life decisions with scientifically justified, model supported evidence. By deepening process understanding and focusing experimentation where it matters most, programs can improve capital efficiency, compress timelines, and reduce CMC development spend by 60% or more in select cases through more efficient CDMO transfers and faster paths to market.

Using mature mechanistic, first principles models and deep regulatory experience, we enable risk based projections that can support filings ahead of long term data while strengthening Module 3 narratives and reducing CMC uncertainties that impact valuation in partnering, M&A, and exits. Delivered as Modeling as a Service, our infrastructure, governance, documentation, and FDA ready quality practices let you benefit without building internal modeling capability. With a strong track record supporting model informed FDA submissions, we help teams reach filing faster with lower risk, more reliable supply, protected investment, and stronger licensing value.