Drug development is complex, costly, and full of late stage risks. Most failures occur after significant investment has already been made. In silico modeling offers a smarter way forward.
Pharmatech Associates, a USP company, applies advanced digital modeling to help emerging and established biopharma companies identify risks earlier, compress development timelines, and strengthen CMC strategies. Our FDA aligned modeling services help you move with confidence, protect investments, and maximize out licensing value.
Every program is unique. Our modeling platform allows you to test and refine CMC strategies virtually, before committing resources. By simulating critical decisions and outcomes, we help you:
Whether your focus is out licensing, accelerated development, or scaling with limited resources, our team empowers you to make confident, data driven choices.
The FDA has encouraged the use of modeling and AI in drug development for nearly a decade, with hundreds of submissions referencing these tools. Pharmatech ensures your modeling strategy aligns with regulatory expectations to:
Case Example
A small biotech reduced its development timeline by more than 60 percent using Pharmatech modeling tools. In under eight months, the program advanced from design to tech transfer, gained pre IND alignment with the FDA, and entered Phase I manufacturing without pilot scale delays
In silico modeling drives measurable efficiencies compared to traditional approaches.
Typical Timelines
| Phase | Traditional | With Modeling |
| Process Design | 6 months | 1–2 months |
| Lab Scale | 4 months | 1 month or skipped |
| Scale Up | 6 months | 2–3 months |
| Tech Transfer | 4 months | 1–2 months |
| Total | 20 months | 6–8 months |
Typical Cost Savings
| Drug Type | Traditional CMC Costs | With Modeling | Savings |
| Small Molecule | $10M | $3–4M | $6–7M |
| Biologic | $50–100M | $15–25M | $35–75M |
Whether you are preparing an IND, evaluating out licensing, or scaling for commercialization, Pharmatech Associates provides the modeling expertise to reduce risk, shorten timelines, and unlock value
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
510.732.0177
22320 Foothill Blvd. Suite 330, Hayward CA 94541
