:: ENEM CONSULTING ::

Medical Devices
IVDs
Combination Products

Clinical and Quality Systems support

Regulatory Regulatory Strategy Regulatory and Project Planning Regulatory Submissions FDA Communication & Submission Management Due Diligence Clinical Support Clinical Planning, Strategy & Operations Clinical Site Audits CRO Audits GLP Audits Quality System Support Quality Systems Development Preclinical Test Planning Training Supplier Audits	Clinical site Audits Auditing of clinical study sites towards preparation for FDA BIMO audits, including: Regulatory Documentation review Institutional Review Board (IRB) Review Informed Consent and Individual Subject Issues Adverse Event (SAE/AE) Reporting Product Accountability Protocol Deviations Source Documentation review against Case Report Forms (CRFs)