Brandwood CKC
A regional office providing regulatory, quality, pharmacovigilance, clinical and commercial advisory services for pharmaceutical and medical technology organisations in Australia and the Asia–Pacific region. The team offers regulatory affairs and product lifecycle support for medicines, biologics and medical devices/IVDs, pharmacovigilance and post-market compliance, clinical research and program management, and related commercial/regulatory strategy.
Industries
Nr. of Employees
small (1-50)
Brandwood CKC
Sydney, New South Wales, Australia, Oceania
Services
Advisory and operational support for regulatory submissions, strategy and interactions in Australia and the APAC region.
Regulatory and quality support across the device lifecycle, including pre-market and post-market activities.
Safety surveillance, adverse event reporting and patient inquiry management including related documentation standards.
Development and maintenance of quality systems to support regulatory compliance across development and commercial operations.
Clinical operations, program management and project delivery support for clinical and commercial programs.
Assessment of promotional and compliance materials to ensure alignment with regulatory requirements.
Advisory and operational support for regulatory submissions, strategy and interactions in Australia and the APAC region.
Regulatory and quality support across the device lifecycle, including pre-market and post-market activities.
Safety surveillance, adverse event reporting and patient inquiry management including related documentation standards.
Development and maintenance of quality systems to support regulatory compliance across development and commercial operations.
Clinical operations, program management and project delivery support for clinical and commercial programs.
Assessment of promotional and compliance materials to ensure alignment with regulatory requirements.
Expertise Areas
- Regulatory compliance and strategy
- Medical device and IVD regulation
- Pharmacovigilance and safety surveillance
- Quality assurance
Key Technologies
- Unique Device Identification (UDI) and device-tracking systems
- Pharmacovigilance data collection and reporting systems
- Regulatory dossier preparation and submission workflows
- Post-market surveillance processes
News & Updates
Participation or coverage of the Ausbiotech International Conference 2025.
Event listing for OCRA Annual Conference 2024.
Event listing for the 2024 ARCS Australia Annual Conference.
Event listing for AUSMedTech 2024.
Article on regulatory considerations for companion diagnostics in Australia.
Article discussing regulatory convergence and collaboration in Australia and the region.
Participation or coverage of the Ausbiotech International Conference 2025.
Event listing for OCRA Annual Conference 2024.
Event listing for the 2024 ARCS Australia Annual Conference.
Event listing for AUSMedTech 2024.
Article on regulatory considerations for companion diagnostics in Australia.
Article discussing regulatory convergence and collaboration in Australia and the region.