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Current
regulatory awareness
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Early warning of changes in relevant areas of regulation by Health
Departments on Industry
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Confidential
assessment of potential safety or health risks for products
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Confidential
review of advertising claims and their substantiation
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Assistance
with the Industrial Chemicals (Notification and Assessment) Scheme
and the Australian Inventory of Chemical Substances
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Co-ordination
between industry and agencies with respect to technical, scientific
or toxicological evidence
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Assistance
as expert witnesses in legal actions involving adverse reactions or
product liability
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Technical
assessments for acquisitions
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Provision of information to Marketing Personnel as required
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The
review of products for compliance to Deceptive Packaging and Weights
and Measures regulations as required.
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of page
Cosmetics
- Confidential review
of and assistance with the following for Cosmetics
- Assistance with
the Industrial Chemicals (Notification and Assessment) Scheme and assessing
or adding ingredients to the Australian Inventory of Chemical Substances
- Personal representation
to Government Health Departments as the need arises
- Writing of expert
technical reports
- Technical assessment
and assistance with respect to
- Good Manufacturing
Practice (and internal auditing)
- Environmental
aspects, safety and health of existing plants
- Upgrading manufacturing
plants and laboratories
- Codes of practice
and administration of codes for the cosmetic, toiletry and fragrance
industry in Australia
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Compilation and review of published medical and scientific data for
inclusion as supporting evidence in submissions and presentations
to Government authorities eg TGA (Australia) and Medsafe (New Zealand)
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Compilation and submission of applications
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For registrations for Therapeutic Goods onto the Australian Register
of Therapeutic Goods
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For
listings for Therapeutic Goods onto the Australian Register of
Therapeutic Goods via the Electronic Lodgement Facility (ELF)
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Confidential review of and assistance with the following for Therapeutic
Goods:
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Advertising
claims and their substantiation
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New
and existing products and their claims
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Ingredients
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Packaging and labels
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Potential
safety or health risks
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Generating
supportive data for claims
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Importing,
exporting, manufacturing and marketing
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Personal representation to Government Health Departments as the need
arises
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Technical assessment and assistance with respect to
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Good
Manufacturing Practice (and internal auditing)
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Environmental aspects, safety and health of existing plants
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Upgrading manufacturing plants and laboratories
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Compilation of registrations for Therapeutic Devices onto the Australia
Register of Therapeutic Goods
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Compilation of inclusions and listings for Therapeutic Devices onto
the Australian Register of Other Therapeutic Goods via the Device
Electronic Application System (DEAL)
- Notification of
Therapeutic Devices to Medsafe New Zealand via Web Assisted Notification
of Devices (WAND)
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Review of formulations for conformity to the FSANZ Foods Standards
code
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Compliance with compositional and definitional standards
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Advice on Foods laws and Fair Trading laws
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Advice on Foods safety standards, handling and hygiene regulations
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Confidential review of and assistance with the following for Foods:
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Advertising claims and their substantiation
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New and existing products and their claims
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Ingredients
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Packaging and labels
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Potential
safety or health risks
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Generating
supportive data for claims
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Importing,
exporting, manufacturing and marketing
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Provision of expert technical reports
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Personal representation to Government Health Departments (State and
Federal) as the need arises
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Technical assessment and assistance with respect to
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Good
Manufacturing Practice (and internal auditing)
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Environmental aspects, safety and health of existing plants
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Upgrading manufacturing plants and laboratories
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