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 that have no prior regulatory precedent and, executing on the same. For platform technologies, ENEM Consulting can develop a plan for a phased launch of multiple applications, leveraging relevant preclinical and clinical history in the context of sequential submissions.
Services include defining regulatory strategy for US and international market launch, including device classification and path to market.
Regulatory and Project Planning
Services include translating regulatory strategy into a project plan, including pre-clinical and clinical deliverables
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.