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
Bioscience Achievement Awards Announced
3 March 2010 - The 2010 BioSA Bioscience Achievement Awards have today recognised two women for their outstanding contributions to the bioscience sector in South Australia. (read more...)
Adelaide research impact brings national awards
3 March 2010 - University of Adelaide researchers have won two of the five categories in the inaugural Scopus Young Researcher of the Year Awards, to be presented tonight by Senator Kim Carr. (read more...)
BNC210 Clinical Trial Results Confirm Safety and Indicate Reduced Stress Hormone Levels
2 March 2010 - Bionomics Limited (ASX: BNO) today announced the final results of its Phase Ia clinical trial of BNC210. (read more...)
BioSA Networking Forum & Presentations
FLINDERS IN THE CITY
Date: Thursday, 29 April 2010
Time: Presentations from 5.30pm followed by networking to 8.30pm
Venue: 182 Victoria Square, Adelaide. (Old Reserve Bank Building)
(read more...)
Australasian Association of Bioethics and Health Law
1-4 July 2010 - The University of Adelaide (read more...)
LESANZ Annual Conference 2010
22-24 April 2010, InterContinental Hotel, Adelaide (read more...)
