A truly effective regulatory strategy does more than secure approval; it actively shapes smarter product development and characterization in the face of uncertainty. It integrates science-driven risk assessments with a nuanced understanding of both evolving expectations and the reality that sponsors must reconcile disparate guidelines across multiple health authorities, often with different risk tolerances and evidentiary standards. Our strength lies in being a deeply technical, science-based organization that understands products across the innovation spectrum, from first-in-class therapies to complex generics and biosimilars, enabling us to architect robust, efficient pathways even where expectations are fragmented or not fully defined. With integrated expertise in quality, Regulatory Affairs, and CMC, our team structures strategies, narratives, and supporting studies that leverage the sponsor’s best science to manage global regulatory risk, optimize development timelines, and differentiate their products in crowded markets.
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
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
