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The generic drug market is a cornerstone of global healthcare, delivering affordable alternatives that reduce costs and expand access. Yet bringing generics to market poses significant Regulatory and scientific challenges-particularly demonstrating safety, efficacy, and quality without duplicative trials. Literature-Based Submissions (LBS) offer a smart, efficient bridge, leveraging existing high-quality evidence to support applications for generic molecules with modified formulations or usage profiles.
This whitepaper explores five pivotal benefits of using LBS for generic drug development and submission. As a global provider of Regulatory medical writing services, we help life sciences and pharma clients seamlessly employ LBS-accelerating market entry, reducing costs, and enhancing credibility through skilled evidence synthesis.
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