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Linical's Regulatory Strategy and IND Support team provides expertise and resources to help early stage clients bring products into clinical development. We support biologics, drugs, and medical devices with a comprehensive understanding of both regulatory and clinical affairs – blended knowledge that provides sound guidance for our clients. These individuals have over 20 years of experience coordinating pre-IND packages, INDs, IDEs, 510Ks, BLAs/NDAs/PMAs/MAAs, regulatory submission strategies, regulatory meeting preparation and attendance, and clinical trial launches. We have successfully supported US, EU, and Asia Sponsors in their US regulatory filings.