 |
 Home
 About Us
Quality Assurance
Regulatory Affairs
Reimbursement
Clinical Trials
Medical / Business Writing
Useful Links
Contact Us
|
 |
About Us
Who we are
QRC Solutions specialises in providing companies with assistance in the commercialisation of therapeutic products through the establishment of strategies directed towards:
- The establishment of Quality Management Systems that are compliant with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), as well as with a range of international standards, including ISO 9001, ISO 13485, ISO 17025, ISO 15189, FDA's QSR and Canada 's CMDCAS.
- Obtaining marketing clearance for therapeutic products in the major markets of Australia , Europe and North America (the US and Canada ), as well as other regulatory jurisdictions such as those of South East Asia .
- Obtaining reimbursement from governments and health providers in these major markets.
- Ensuring that clinical trials are conducted in accordance with GCP guidelines.
What we Offer
- Experience in the biotech industry.
- Experience in working with start-up companies.
- Strategic Planning.
Associations
Membership in the following societies:
- AusBiotech.
- Asia Network for Biotechnology (ANB).
- Association of Regulatory and Clinical Scientists (ARCS).
- Australian Institute of Company Directors (AICD).
- Australian Institute of Management (AIM).
Mission
QRC Solutions aims to further the development of the Biotechnology industry by providing a specialised and personalised consulting service to assist biotech companies in the strategic planning and implementation of their commercialisation process.
|
