The United States pharmaceutical market offers unmatched potential, but entry requires more than translating a dossier, it requires aligning regulatory strategy, CMC, quality systems, and operational readiness to FDA expectations. Pharmatech Associates, a USP company, brings over 30 years of experience helping global companies enter and scale in the U.S. across APIs, small molecules, and biologics. We leverage deep familiarity with global health authority frameworks to bridge gaps between existing development work and FDA expectations for both the dossier and the site, applying a proven, phase-appropriate roadmap that integrates submission strategy with inspection readiness and day-one operational execution.
The result is a faster, lower-risk path to U.S. approval and commercial readiness, because regulatory, quality, and operations are aligned from the start, not treated as separate workstreams.
Entering the US means addressing competitive positioning, FDA expectations, and market specific requirements. We assess your existing data, facilities, and systems to create a clear path toward regulatory approval.
Our support includes:
Case Study: Closing Gaps to Enable a US IND
An Asia based cell therapy company engaged Pharmatech to identify and close critical gaps that would have prevented US commercialization. We created a scientific and regulatory roadmap, addressed FDA expectations, and streamlined post approval commitments.
Impact for the client:
✔ IND filed successfully in the US
✔ Time to market accelerated
✔ Development costs significantly reduced
Reaching the US market is only the beginning. We help ensure products thrive post approval with strategies tailored to commercialization and growth.
You gain:
Our proactive planning helps you stay aligned with timelines, investment cycles, and evolving regulatory expectations
US regulators and stakeholders increasingly favor domestic manufacturing for quality oversight, responsiveness, and supply chain security. Pharmatech supports both US and international clients in near shoring or reshoring to align business and compliance goals.
We help you:
Whether you are pursuing federal incentives, risk mitigation, or closer to market supply, we align your manufacturing strategy with regulatory expectations.
Pharmatech Associates, a USP company, is your trusted partner for US market entry. We help you bridge global to US regulatory gaps, accelerate approvals, and build sustainable strategies for long term success.
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
