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