Regulatory Affairs

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.