Small molecule programs can look straightforward until shifting guidance, API and impurity risks, tech transfer friction, and manufacturing realities drive delays, rework, and cost. For API manufacturers and generic sponsors, success hinges on the fundamentals: route and impurity control, robust specs and methods, supplier and data integrity, and a CMC strategy that supports ANDA or 505(b)(2) requirements, bioequivalence expectations, and inspection readiness across sites and partners.
Pharmatech Associates, a USP company, helps you move faster with less risk by integrating API and drug product CMC, quality systems, regulatory strategy, and operational readiness into one execution plan. We translate requirements into practical actions across process and analytical development, impurity strategy, stability and control strategy, CQV readiness, and CDMO and supplier oversight. The result is fewer surprises, smoother filings and transfers, stronger manufacturing performance, and better capital efficiency.
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
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
