Bringing innovative therapies to patients depends on a well-defined regulatory pathway. Without it, programs risk delays, unexpected agency questions, and costly rework. Regulatory expectations evolve quickly, and success requires anticipating agency needs from the start. Pharmatech Associates, a USP company, helps you design regulatory strategies that reduce risk and accelerate approvals. Our team includes former regulators and seasoned industry experts with decades of global experience. Together, we help you prepare submissions, engage with health authorities, and move confidently from development through approval
Early engagement with regulatory experts saves time and avoids surprises. Whether you are preparing an IND, NDA, ANDA, or BLA, we analyze your current data, identify potential gaps, and build a roadmap aligned with your objectives. Our submission-readiness assessments and global strategy support keep your program on track
Case Study: Faster Approval Through Smarter CMC Strategy
A client with strong Phase I results sought fast-track designation. Anticipating the opportunity, Pharmatech guided them to manufacture three full-scale Phase I lots. This simplified their CMC narrative, eliminated comparability risks, and allowed the same lots to be used for Phase II.
Impact for the client:
✔ Regulatory risk reduced
✔ Approval accelerated by 3 to 6 months
✔ Program advanced with zero CMC issues raised
From pre-IND planning through commercialization, we help you anticipate agency expectations, prepare submissions, and manage lifecycle requirements across global markets. Our experience spans biologics, cell and gene therapies, orphan drugs, and complex combination products
What you gain:
Strong regulatory strategy gives you speed, confidence, and clarity. Pharmatech Associates helps you avoid costly setbacks, build trust with agencies, and accelerate your path to approval
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
