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:

• Australia
• Canadian Authorities
• CBER
• CDER
• CVM
• EMA
• FDA
• Gulf Cooperation Council
• IMB
• Mexican Ministry of Health
• MHRA
• NM Board of Pharmacy
  

Recent Inspections

2012

• FDA-CDER - General Inspection/PAI

2011

• PDMA - General Inspection/ Product Specific
• NM Board of Pharmacy - Controlled Substance
• FDA-CBER - General Inspection/ PAI
• DEA - Controlled Substance

2010

• 2010 ANVISA - PAI/
  General Inspection
• EMA - General Inspection
• FDA-CBER - General Inspection
• Mexican Ministry of Health -
  PAI/General Inspection

2009

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

2008

• FDA-CDER – General Inspection/PAI
  
• EMEA – General Inspection

2007

• ANVISA – General Inspection
  
• CDER – General Inspection