Technical assistance, documentation development, training, and auditing—we’ve done it all for a variety of management system standards, and will help you comply and enhance your bottom line.

Our experience includes these, among others:

  • 21 CFR 210
  • 21 CFR 211
  • 21 CFR 800
  • 21 CFR 820
  • cGLP
  • cGMP
  • ICH Q7A
  • ICH Q8(R1)
  • ICH Q9
  • ICH Q10
  • ISO 9000:2000 & ISO 9000:2008
  • ISO 14000:2004
  • ISO 13485:2003
  • ISO 14971:2007
  • ISO / TS 16949:2002