Streamline Regulatory offers:

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• 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

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