Regulatory Affairs

Our Medical & Regulatory affairs team are up to date with the latest pharmaceutical and healthcare practices to ensure consistency with the most recent guidelines, regulations and clinical publications.

Preparation and submission of applications, reports and correspondence to various regulatory agencies.

Creation of documents and submission to the appropriate regulatory bodies (i.e. product complaints, recall).

CTD/ACTD dossier review and gap analysis identification.

Creation of regulatory standard operating procedure documents.

Regulatory affairs filing strategy development.