Whether you are navigating evolving regulatory guidelines, addressing quality system gaps, or working to improve your margin through manufacturing efficiency, small molecule development can be complex. Every setback costs time, resources, and market opportunity. Pharmatech Associates, a USP company, partners with you to overcome these challenges. With decades of experience and a track record of successful approvals, our consultants help your small molecule projects advance more smoothly, more swiftly, and with greater confidence
Regulatory expectations for small molecules continue to shift as agencies refine their definition of “state of the art.” We work with you to ensure your program aligns with current standards and future requirements, so you can move forward without costly rework
The small molecule pathway is well established, but frequent updates create new risks, especially when adapting ex-US programs for US submission. Pharmatech helps you anticipate these changes, build strong regulatory relationships, and secure approvals efficiently
Case Study: Faster Market Entry Through Smarter Strategy
“We launched up to six months earlier.”
A client’s new chemical entity had the potential for breakthrough status. Working together, we amended their CMC strategy at Phase 1 to support commercial-scale quantities.
Impact for the client:
✔ Breakthrough drug status granted
✔ CMC comparability simplified
✔ Phase 1 clinical lots reused for later filings
✔ Approval accelerated by 3 to 6 months
Unexpected issues in small molecule manufacturing can take products off the market or cut into margins. We help you identify root causes quickly, design corrective actions, and return your program to stability while staying compliant with global standards
Case Study: Ending 18 Months Off Market
“We restored supply and eliminated 10 percent batch loss.
A multinational client faced dissolution failures in a spray dried modified release capsule, losing 10 percent of batches annually and forced to withdraw the product from the market.
Impact for the client:
✔ Root cause identified within 6 weeks
✔ Predictive model created for dissolution performance
✔ Product relaunched after 18 months off market
✔ No further quality issues reported
Whether you are preparing for approval, solving a manufacturing challenge, or building for long-term success, Pharmatech Associates can help you move forward with clarity and confidence
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
