EMINENT is registered with the following government agencies and possesses the required permits and licences to conduct business in performing these Investigational Drug Management Services:
FDA Registered Drug Establishment
NDC Labeler Code
MD State Pharmacy Distributor License
MD State Pharmacy License
MD State Controlled Dangerous Substance
DEA Manufacturing / Distribution / Research / Pharmacy Registration
Frederick County Alarm Permit
EPA Regulated Waste ID
MD State Special Medical Waste ID
EMINENT facilities are operated under strict compliance with current Good Manufacturing Practice Regulations (21 CFR 211) and all applicable Federal, State, and local regulations.
All operations are covered under a body of Standard Operating Procedures (SOPs). Test equipment and facility monitoring devices are calibrated using manufacturer recommended calibration test procedures.
Health and Safety issues are well addressed by strict implementation of Facility Safety Plan, Health and Safety Manual, hazardous material spill clean-up plan, and Laboratory Hygiene Plan in compliance with OSHA Laboratory Standard 1910.1450.