Comprehensive Solutions
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
Regulatory Strategy
Services include defining the US and international market launch regulatory strategy, including device classification and path to market.
Regulatory & Project Planning
Regulatory Submissions
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 Submissions
Combination Products
International Submissions
IVDs
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.
Due Diligence
Services include independent regulatory appraisals of potential acquisition, diversification and licensing candidates.
