:: ENEM CONSULTING ::

Medical Devices
IVDs
Combination Products

Regulatory Support

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.


Regulatory	Clinical Support	Quality System Support
Regulatory Strategy Regulatory and Project Planning Regulatory Submissions FDA Communication & Submission Management Due Diligence	Clinical Planning, Strategy & Operations Clinical Site Audits CRO Audits GLP Audits	Quality Systems Development Preclinical Test Planning Training Supplier Audits