Remediation Consulting, LLC provides regulatory affairs oversight throughout the product life cycle; starting with concept and feasibility, through design / development and specification setting, into clinical and regulatory submission (e.g. NDAs / ANDAs, PMAs, 510Ks, Establishment Registrations, etc.) and updates.   

 

This includes consultative support for pre-requisite activities culminating in eCTD (et. al.) submission processes, and followed by associated tracking, responses to complete response letters, informational request letters, amendments, supplements, etc.  Remediation Consulting, LLC also contributes to remediation strategies needed for successful regulatory status and approvals by applicable domestic and international regulatory authorities (FDA.gov, ISO.org, DEA.gov, ICH.org, EC.europa.eu).

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"At FDA, our mission is to promote and protect the health of the public."  -  Margaret Hamburg