If you’re developing a product that builds on an existing drug — whether it's a new indication, formulation, or delivery method — the 505(b)(2) pathway could be your fastest, most cost-effective route to approval. But early mistakes in regulatory strategy, bridging study plans, or CMC strategy can limit potential long-term benefits.
Harnessing our deep experience addressing the nuanced demands of 505(b)(2) submissions, our white paper, Understanding the 505(b)(2) Approval Pathway, discusses ways to help you leverage existing data, reduce clinical burden, and accelerate approval timelines.
What you'll learn:
- How the 505(b)(2) pathway differs from 505(b)(1)
- Which products are ideal 505(b)(2) candidates
- Common pitfalls that can delay or derail your program
Don’t Just Choose a Path — Own It
Experience matters when it comes to navigating the 505(b)(2) approval pathway. Download our white paper for tips to optimize your 505(b)(2) program based on decades of success. Or connect with us and leverage our deep expertise to build a your streamlined 505(b)(2) strategy.
Premier Research International LLC is a leading global CRO and consulting partner with expertise in driving a smarter, faster path to approval. Premier offers full-service support for 505(b)(2) drug development programs with a proven track record of guiding hundreds of sponsors to approval. Our cross-functional team, with services spanning regulatory strategy, clinical pharmacology and PK modeling, nonclinical planning, and CMC strategy, will help you to bridge the gap between innovation and efficiency to advance your product from concept to commercialization.
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