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.
EMINENT is registered with the following government agencies and possesses the required permits and licenses to conduct business in performing these Investigational Drug Management Services:
FDA
February 2020
August 2015
January 2010
March 2006
April 2003
August 2002
PMDA (Japan)
September 2006
State Board of Pharmacy
Annual
MPA (EMEA)
November 2013
June 2010
October 2005
August 2002
MIT (Russia)
July 2018
ANVISA
April 2008
March 2010
