Regulatory and Manufacturing
Bio Innovation SA has a regulatory affairs group to assist life science companies and research organisations in identifying the regulatory requirements for development. Regulatory assistance is provided to both service providers and product developers to undertake work in the areas of preclinical, clinical trials and manufacturing.
A key objective in this area is to advise South Australian bioscience companies and research organisations on all aspects of regulatory affairs, and to provide appropriate linkages and access to the TGA, FDA, NATA and the Office of the Gene Technology Regulator (OGTR).
Regulatory assistance is provided in the areas of:
- Pre-clinical and clinical product development
- Regulatory compliance
- Regulatory submissions
- Labeling and Advertising
- Reimbursement submissions
- Pharmacovigilance
- Quality Management Systems, including GMP, GLP and GCP
For further information, please contact info@bioinnovationsa.com.au or phone +61 8 8217 6400.
Bio Innovation SA
Level 15/33
King William Street
Adelaide SA 5000
Australia
Phone:61 8 8217 6400
Fax:61 8 8217 6416
War Stories – Lessons Learnt by The Medical Devices Partnering Program
13 September, BioSA Incubator (read more...)
HUPO 2010
19 - 23 September, Sydney Convention and Exhibition Centre (read more...)
Translational Research Excellence 2010 Conference (TRX10)
11-13 October, Brisbane Convention and Exhibition Centre (read more...)
Medical Device Regulation Workshop
18 October 2010 (read more...)
