SERVICES

Streamline Regulatory offers:

  • Regulatory support to clients on devices and combination products

  • 510(k)s, IDEs, Pre-Submissions, PMAs, 513(g)s, HDEs, and Requests for Designations submissions

  • Nonclinical and clinical study design and evaluation

  • Regulatory strategy documents

  • FDA meetings and interactions

  • Due diligence evaluations

  • Litigation expert witness testimony

Questions? Contact us

We are here to assist. Contact us by phone or email.