Regulatory Compliance, Strategy & Submissions
From registration application preparation, submission and management through to approval, regulatory problem-solving and administrative appeals, Brandwood CKC aims to be an integral part of your team and will work with you every step of the way.
We support you to prepare complete Technical Files and regulatory dossiers. We specialise in risk assessments, Literature-Based Submissions, and medical writing capabilities for medicine Module 2 overviews and summaries.
We offer in-house eCTD and NeeS publishing services.
At a Glance:
US FDA 510(k), de Novo and PMA