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Strategy and Agency Communications:
Coderant is often engaged to develop macro regulatory and clinical strategies in conjunction with Regulatory Agency communication. Acting as an agent for our Clients, Coderant is adept in navigating Agency concerns and facilitating efficient communication while documenting Agency agreements.
Clinical Monitoring
Coderant is staffed to fully monitor and audit a myriad of clinical studies. Coderant’s teams, which include both Clinical Research Associates and licensed medical doctors, ensure accuracy of data transfer, data integrity and adherence to protocol.
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Regulatory Submissions
Coderant specializes in authoring marketing applications which are complete, concise, logical, persuasive and most important—anticipate Agency concerns. Our teams have successfully authored a number of regulatory filings, including, INDs, BLAs, NDAs, IDEs, 510(k)s, PMAs, DMF’s and Technical Dossiers.
Due Diligence and M&A Review
Stemming from its venture capital foundation, Coderant has often been asked to provide disinterested third-party evaluations of regulatory and clinical programs in view of financing or merger/acquisition transactions.
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