BioClin’s independent quality assurance unit has a proven track record of successful FDA, GLP and cGMP inspections.

BioClin's independent quality assurance unit has a proven track record of successful FDA, GLP and cGMP inspections. The unit ensure compliance to current SOP's, GLP, cGMP and ICH guidelines and regulations.

BioClin is a GLP compliant laboratory in accordance with EC Council Directive, 1999/11 EEC of 8th March 1999, (No. L 77/9), The OECD Principles of Good Laboratory Practice NUMBER 1, ENV/MC/CHEM (98) as revised in 1997.		  
   

BioClin independent quality assurance unit ensures;

  • a highly efficient laboratory with excellent data integrity.
  • compliance to GLP, FDA regulations, cGMP and ICH guidelines
  • fast, effective, and thorough auditing, ensuring aggressive timelines are met
  • 21 CFR part 11 compliance on all CDS systems
  • a continual improvement quality system with highly motivated staff

What this means for our clients is quality, confidence and credibility.