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Regulatory and technical services for Australia and New Zealand
- Complementary medicines (dietary supplements) and over-the-counter (OTC) products
- Cosmetics, personal care and household products
- Foods
- New Zealand dietary supplements
Complementary medicines
| Product development |
Formula reviews and development
Advice on eligibility of products and level of registration required
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| Marketing requirements |
Advice on compliance of promotional material, labelling and packaging requirements
Applications for advertising clearance
Assistance with technical writing
Review and compilation of evidence to support product claims as per TGA guidelines |
| Importation |
AQIS ingredient reviews and permit applications
Preparation of product dossiers |
| Stability and GMP requirements |
Development of product specifications
Design and co-ordination of stability trials
Advice on GMP Contract Agreements
Assistance with TGA GMP audits for overseas manufacturers |
| Therapeutic Goods Administration liaison |
Preparation and submission of applications to Australian TGA and other agencies
Assistance with post-market product audits
Advice on potential impact of draft legislation |
Foods
| Product development |
Formula and ingredient reviews
Advice on applicable food standards
Advice on restrictions
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| Marketing requirements |
Advice on compliance of promotional material, labelling and product presentation |
| Importation |
AQIS ingredient reviews and permit applications |
| Food Standards Australia New Zealand liaison |
Preparation and submission of Novel food applications
Assistance with State Health Authority notices
Advice on potential impact of draft legislation |
Cosmetics, personal care and household products
| Ingredient assessment |
Australian Inventory of Chemical Substances (AICS) searchers
Applications to NICNAS for inclusion in the AICS
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| Advice on restrictions |
Review of poisons schedules, quarantine or import issues
AQIS ingredient reviews and permit applications
R and S statements |
| Marketing requirements |
Advice on labelling and packaging requirements
Review and preparation of product claims
Review and preparation of marketing materials |
| NICNAS liaison |
Company registration
Annual report preparation and submission
Form 15 preparation (including MSDS) and submission |
New Zealand dietary supplements
Formula reviews and development
Advice on compliance of promotional material, labelling and packaging requirements |
Staff training
A range of courses is offered for regulatory, technical and marketing staff.
More details ... |
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