To define your pathway and deliver your major milestones, Veranex’s regulatory and quality experts are recognized for their well-established and strong relationships with the FDA, European Medicines Agency, and other international regulatory agencies.
With our track record of successful regulatory submissions in medical devices, in vitro diagnostics, software as a medical device (SaMD), and combination products, we’ll help you determine the optimal regulatory pathway to successfully navigate the submission process.
We also provide full-service quality consulting services to our clients, supporting the development, implementation, and maintenance of clients’ quality management systems, design control support, design history file (DHF) activities, and preparation for and performance of audits/inspections and supplier quality assessments. To optimize your investment, trust our regulatory and quality expertise specifically focused on your MedTech innovation.