ENEM Consulting provides comprehensive, worldwide regulatory solutions for medical devices, IVDs, and combination products. ENEM Consulting has a successful track record of developing a viable regulatory strategy for products with no prior regulatory precedent and execution. For platform technologies, ENEM Consulting can develop a plan for a phased launch of multiple applications, leveraging relevant pre-clinical and clinical history in the context of sequential submissions
Services include defining the US and international market launch regulatory strategy, including device classification and path to market.
Regulatory & Project Planning
Services include developing submission template/table of contents, writing, reviewing, editing of submissions. It also includes assisting with FDA, Regulatory Agency, and Notified Body communications through the submission review process.
FDA Communication & Submission Management
Services include assistance with FDA meetings, teleconferences, and FDA Panel meeting support. Also includes guidance on pre-IDE meeting strategy, support with presentations, and as your liaison with FDA through the pre-IDE review process.
Services include independent regulatory appraisals of potential acquisition, diversification and licensing candidates.