"๐๐ช๐ง ๐ฅ๐ช๐ง๐ฅ๐ค๐จ๐ ๐๐จ ๐ฉ๐ค ๐๐จ๐จ๐๐จ๐ฉ ๐ข๐๐๐๐๐๐ก ๐๐๐ซ๐๐๐ ๐๐ฃ๐ ๐๐๐ฟ ๐๐ค๐ข๐ฅ๐๐ฃ๐๐๐จ ๐๐๐๐๐๐ซ๐ ๐ง๐๐๐ช๐ก๐๐ฉ๐ค๐ง๐ฎ ๐จ๐ช๐๐๐๐จ๐จ ๐๐ฃ๐ ๐๐ค๐ข๐ฅ๐ก๐๐๐ฃ๐๐ ๐๐ฃ ๐ผ๐ช๐จ๐ฉ๐ง๐๐ก๐๐."
Hill Valley Regulatory Consulting was formed in 2023 by Principal Consultant Gary Burgess.
Gary saw a need in the medical technology industry for more knowledgeable, practical, pragmatic and fearless regulatory support for businesses as they navigate their way through the complex regulatory environment in Australia.
๐ Gary runs the business from his home office in Canberra.
๐จ Contact us now to arrange a free and confidential discussion: info@hillvalleyregulatory.com.au
Areas of expertise:
โ
Australian Medical Device Legislation
โ
TGA Processes & Decision Making
โ
Regulatory Strategy Development
โ
Regulatory Intelligence
โ
Regulatory Compliance
โ
Post-market Vigilance & Monitoring
โ
QMS Requirements (ISO13485 & MDSAP)
โ
Australian Therapeutic Goods Advertising Requirements
โ
Industry Codes of Practice
We can assist with a large variety of tasks and issues, including:
๐ Manufacturer certification & product registration with TGA, including:
โ Conformity Assessment applications
โ ARTG applications (inc. Manufacturerโs Evidence)
โ TGA Export Only applications
๐ Regulatory strategy development for successful market launch
๐ Responding to and communicating with the TGA, including pre-submission meetings, requests for further information (s41JA), and appealing initial decisions under s60 of the Act
๐ Delivering in-house training to your staff on medical device regulatory requirements and TGA processes
๐ Reviewing labels and instructions for use (IFU) for compliance with regulatory requirements
๐ Reviewing marketing material for compliance with local advertising regulations and relevant codes of practice
๐ Providing ad hoc ongoing regulatory support & advice
Company Details
- Founded
- -
- Address
- Canberra, Act, Au
- Industry
- Professional Services
- NAICS
-
Professional, Scientific, and Technical ServicesArchitectural, Engineering, and Related ServicesOther Professional, Scientific, and Technical ServicesLandscape Architectural ServicesEngineering ServicesDrafting ServicesBuilding Inspection ServicesGeophysical Surveying and Mapping ServicesSurveying and Mapping (except Geophysical) ServicesTesting LaboratoriesAll Other Professional, Scientific, and Technical Services
- Keywords
- Medical Device Regulations, Quality Management Systems, TGA Submissions, Regulatory Intelligence, Regulatory Strategy, Regulatory Compliance, Advertising Compliance, TGA Processes.
- HQ
- Canberra, ACT
Hill Valley Regulatory Consulting Questions
Hill Valley Regulatory Consulting's website is https://www.hillvalleyregulatory.com.au
Hill Valley Regulatory Consulting's LinkedIn profile is https://au.linkedin.com/company/hill-valley-regulatory-consulting
Hill Valley Regulatory Consulting's industry is
Professional Services
Hill Valley Regulatory Consulting's top competitors are
Cochlear,
Advanced Medical Optics,
Australasian Society For Biomaterials And Tissue Engineering,
Australian Medical Device Sponsors,
Rubicon Consulting,
Mdproject,
Regweb Consulting Services Inc.,
Phenomics Australia,
Pharmalex,
Commercial Eyes Pty Ltd.
Hill Valley Regulatory Consulting's categories are Professional Services
Hill Valley Regulatory Consulting's founding year is 2023
