robert-forbes.com.au - Robert Forbes and Associates - Regulatory and technical advice to suppliers and manufacturers of complementary medicines, dietary supplements, OTC medicines, cosmetics, personal care products and foods.

Complementary and OTC medicines

Product development:
Formula reviews and development - advice on eligibility of products and level of registration required
Marketing requirements:
Advice on compliance of promotional material, labelling and packaging - 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
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 - preparation of product dossiers

Foods

Product development:
Formula and ingredient reviews - advice on applicable food standards - advice on restrictions
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) searches - applications to NICNAS for inclusion in the AICS
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 and 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

Staff training

A range of courses is offered for regulatory, technical and marketing staff - Click here for details