The United States pharmaceutical market offers unmatched potential, but entry requires navigating a distinct and demanding regulatory landscape. Global experience alone is not enough. FDA standards for quality, safety, and manufacturing readiness require specific expertise. Pharmatech Associates, a USP company, partners with international and domestic firms to bridge regulatory gaps, streamline CMC strategies, and prepare programs for successful FDA submission and approval. Our experience guiding product launches across multiple regions allows us to leverage existing work while aligning with US requirements
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
22320 Foothill Blvd. Suite 330, Hayward CA 94541
