Quality & Compliance

OsoBio has an impressive track record of regulatory compliance and a strong inspection history. Our intensive quality assurance support and project management protocols are second-to-none—assuring you of ongoing, thorough communication and strict attention to timelines and budgets.

OsoBio has received the approval of the following agencies:

  • ANVISA - Brazil
  • Therapeutic Good Administration - Australia
  • Health Canada
  • EMEA
  • Gulf Cooperation Council
  • NM Board of Pharmacy
  • FDA
    • CBER
    • CDER
    • CVM

Recent Inspections

2009

  • NM Board of Pharmacy - General Inspection
  • MHRA - GMP Inspection for H1N1 filling

2008

  • CDER – General Inspection and PAI
  • EMEA – General Inspection

2007

  • ANVISA – General Inspection
  • CDER – General Inspection

2006

  • CDER – 2 PAI’s/General Inspection
  • NM Board of Pharmacy – General Inspection
  • Gulf Cooperation Council