The GxP Compliance Australia is an Australian business, specialising in delivery of Quality Assurance (QA) services in Australia & New Zelaand for pharmaceutical sector, biotechnology companies and academia, across a range of compliance areas, including Good Clinical Practices (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP) etc.
Our QA services apply to all stages of medicine’s life cycle, spanning from the first-in-human-clinical trials, through authorisation and regulatory approval, the marketing and supply stage, up to the end of life and discontinuation of withdrawal from the market.
The examples of our QA services include:
AUDIT
• Management of the GxP Audit Program
• GCP Audit of a clinical trial site, sponsor or vendor
• GVP Audit of the pharmacovigilance system managed by a medicine sponsor or a vendor
• GCLP Audit of a clinical laboratory
• GMP Audit of a manufactoring site or vendor.
INSPECTION
• TGA inspection readiness – assessment and action plan
• Mock inspection
• Hosting regulatory inspections by the TGA or comparable overseas regulators.
QMS
• QMS Assessment and gap analysis
• Management of quality issues
• Management of SOPs, supporting compliance with the Australian & New Zealand regulations.
For more information, please contact: kasia.hoffler@gxpcompliance.com.au.
Company Details
- Founded
- -
- Address
- Australia, Au
- Industry
- Health And Human Services
- NAICS
-
Administration of Human Resource ProgramsAdministration of Veterans' Affairs
- Website
- http://gxpcompliance.com.au
- Keywords
- Assuring safety and quality of the therapeutic goods across all stages of their life cycle..
- HQ
- Australia
Gxp Compliance Australia Questions
Gxp Compliance Australia's website is http://gxpcompliance.com.au
Gxp Compliance Australia's LinkedIn profile is https://au.linkedin.com/company/gxp-compliance-australia
Gxp Compliance Australia's industry is
Health and Human Services
Gxp Compliance Australia's top competitors are
Migration4u,
Therapeutic Goods Administration,
Training Online 4u,
Australian Visa Group,
Roar Talent International,
Ispe Australasia Affiliate,
Lucia Bio,
Jupiter Commodities Inc,
Allington Associates,
Prism Health, Inc..
Gxp Compliance Australia's categories are Health and Human Services
Gxp Compliance Australia's founding year is 2023
