Regulatory Submission Compliance Audits

Is your firm in compliance with the terms of your NoC (Notice of Compliance) and the commitments made during your submission review or marketing authorization? Is your regulatory filing current and up-to-date?   Have you recently acquired a new product or new company and need to verify whether the submission dossier is current?  Are you considering changes to your approved suppliers or processes and want a third-party opinion on regulatory impact of pending changes?

DSA handles all types of submission audits to assess compliance with both the market authorization and current regulations.