Regulatory Affairs
Click here to see our Regulatory Affairs services- Current regulatory awareness
- Early warning of changes in relevant areas of regulation by regulatory authorities on industry
- Confidential assessment of potential safety or health risks for products
- Confidential review of advertising claims and their substantiation
- Assistance with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) now known as the Australian Industrial Chemicals Introduction Scheme and the Australian Inventory of Chemical Substances (AICS)
- Co-ordination between industry and agencies with respect to technical, scientific or toxicological evidence
- Technical assessments for acquisitions
- Provision of information to marketing personnel as required
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- The review of products for compliance to the National Trade Measurement Act and Regulations.
Cosmetics
Click here to see our Cosmetics services- Confidential review of ingredients in cosmetic products to ensure they are on the AICS and are not restricted by entries in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
- Confidential review of packaging to check country of origin, trade measurement and ingredient labelling compliance
- Advice on cosmetic versus therapeutic claims
- Advice on claims for new or competitor products
- Advice on manufacturing, marketing, import or export of cosmetic products
- Assistance with registration with NICNAS / AICIS as a cosmetic or industrial chemical importer
- Interaction with NICNAS /AICIS to notify or exempt new ingredients not on AICS including writing notifications and permit applications
- Advice on the safety or health risks of cosmetic or industrial chemical ingredients and products
- Advice on the writing of Safety Data Sheets (SDSs) to the Australian approved format
- Advice on compliance with NICNAS / AICIS Cosmetic Guidelines and Cosmetic Standard
- Compliance with Environmental Protection Authority (EPA) New Zealand Group Standards including the Cosmetic Group Standard.
Medicines, Sunscreens and Disinfectants
Click here to see our Medicines, Sunscreens & Disinfectants services- Compilation and submission of applications for:
- Registrations for Therapeutic Goods onto the Australian Register of Therapeutic Goods (ARTG)
- Listings for Therapeutic Goods onto the ARTG via the Therapeutic Goods Administration’s (TGA’s) eBusiness Services (eBS) website
- New excipients to be added to the ARTG via the TGA’s eBS website
- Medicine/poisons scheduling to the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS)
- Product areas include OTC medicines, complementary medicines, nutritional supplements, traditional medicines, sunscreens and disinfectants.
- Confidential review and assistance with the following for Therapeutic Goods:
- Advice on claims for new or competitor products
- Ingredients
- Packaging and labels
- Potential safety or health risks
- Importing, exporting, manufacturing and marketing
- Compilation and review of published medical and scientific data for inclusion as supporting evidence in submissions and presentations to government authorities e.g. Therapeutic Goods Administration (TGA) Australia and the New Zealand Medicines and Medical Safety Authority (Medsafe):
- Submissions to TGA of APIs and Complementary Medicines Actives
- Submissions to TGA of data and excipients
- Personal representation to government health departments (state and federal)
- Related Product Notifications to Medsafe (NZ)
- Medsafe (NZ) registrations
- Safety assessment and assistance with respect to:
- Pharmaceutical, herbal and sunscreen actives
- Finished products
- Technical assessment and assistance with respect to:
- Good Manufacturing Practice
- Self GMP audits
- Stability studies
- Finished product specifications
- Sponsor/ Manufacturer GMP contracts
- Quality Assurance documents
Medical Devices
Click here to see our Medical Devices services- Compilation of inclusions for Therapeutic Devices onto the ARTG via the TGA’s eBS website
- Confidential review and assistance with the following for Therapeutic Devices:
- Advice on claims for new or competitor products
- Ingredients
- Packaging and labels
- Device application audits
- Importing, exporting, manufacturing and advertising review
- Notification of Therapeutic Devices to Medsafe (NZ) via Web Assisted Notification of Devices (WAND).
Foods
Click here to see our Food services- Review of formulations for conformity to the Food Standards Australia New Zealand (FSANZ) Food Standards Code
- Advice on food laws and fair trading laws
- Advice on Food Safety Standards and hygiene regulations
- Confidential review and assistance with the following for foods:
- Advice on claims for new or competitor products
- Ingredients
- Packaging and labels
- Potential safety or health risks
- Generating supportive data for claims
- Importing, exporting, manufacturing and marketing
- Personal representation to government authorities
- Technical assessment and assistance with respect to Good Manufacturing Practice (and internal auditing)