FDA, Good Manufacturing Practices GMP, quality system QSR, ISO 13485 regulatory consultants manufacturing development device, drug, diagnostic, combination medical products, 510(k), PMA, IDE

Regulatory Submissions -
Strategies, Action Plans, Approvals

The Tamarack Group’s broad consulting experience and strategic insights help develop regulatory approval strategies and concrete action plans for gaining market access and competing in today’s complex and global market. We help plan, prepare, and interact with regulatory agencies on –

  • Requests for designation of agency jurisdiction (RFD)
  • Investigational Device Exemption (IDE) submissions
  • Premarket Notification (510(k)) submissions
  • Premarket Approval (PMA) submissions
  • Chemistry, Manufacturing, and Control (CMC) sections of Investigational New Drug applications (INDs), New Drug Approval applications (NDAs), and Biologic License Applications (BLAs)
  • Common Technical Document (CTD) Module 3 – Quality documents
  • Drug Master Files
  • Facility Design Reviews

We request pre-submission FDA meetings, plan and prepare pre-meeting packets, lead or support your team during FDA meetings, and help ensure that meeting outcomes are understood and communicated.

The Tamarack Group guides medical device and diagnostic developers and manufacturers in the selection of Notified Bodies, interactions with foreign Health Ministries, and preparation of Technical Files and Dossiers for European CE Mark certification.