Quality & Regulatory Services

Quality & Regulatory Services

Olympus Biotech Manufacturing Quality & Regulatory Services

Quality Assurance                                      

 

We are compliant with US/FDA regulations for both biologics and medical devices.  We hold GMP certificates from the EMA and TGA and we are ISO 13485 certified.  Our quality systems are very mature and include the use of validated electronic systems for training, CAPA, audits and documentation. 

 

We comply with: 

  • 21 CFR Parts 210, 211 and 820 
  • Canadian MDR (SOR/1998-282) 
  • Australian Human Therapeutic Goods Act, 1989 
  • EC Directive 2003/94/EC

 

 

 

EVENTS

January 12th - 17th, 2014

CHI's Peptalk 2014
The Protien Science Week
Palm Springs, CA

 

January 28th - 31st, 2014

WTG's Biomanufacturing Summit 2014
San Diego, CA