REGSolutions, LLC is a highly experienced regulatory consulting firm specializing in providing creative strategies for gaining US FDA medical device clearance and approvals. With over 30 years of real-world experience in the industry, they understand the importance of balancing business growth with regulatory compliance, offering assistance with quality management systems, international submissions, FDA liaison, and clinical services.
From international corporations to local startup firms, REGSolutions has successfully helped companies of all sizes navigate the complex regulatory landscape, ensuring their products meet federal and international regulations. With a deep understanding of changing FDA policies and the challenges of European EU clearance, their seasoned regulatory professionals can develop strategic plans to get products to market and guide them through the CE marking process.
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