Mile High Regulatory Consulting

Mile High Regulatory Consulting provides regulatory affairs consulting services for the medical device and pharmaceutical industries with a primary focus on doing the right thing for people (patients, clients, customers, etc.). This approach is achieved through integrity, compliance and highly effective regulatory strategies to foster successful products and viable regulatory submissions. Services: -Regulatory Affairs Strategy -Regulatory Submissions: Device Classification (513(g)), Pre-Submissions, Premarket Notification (510(k)), Premarket Authorization (PMA), De Novo applications, EU Technical Files for CE marking, Summary Technical Document (STED) -Regulatory Affairs Change Assessments -Regulatory Affairs Acquisition Assessments -Gap Analysis Assessments: Regulatory Strategy, Regulatory Submissions, Regulatory Submission documents (e.g., verification and validation reports, etc.) -Marketing and Advertising Review -Training