New Product Development
RFA Regulatory Affairs can now guide you from initial concept to successful product launch. We provide technical advice, product development expertise, and regulatory experience to assist you in the launch of your listed complementary medicine or food product. We work closely with your team, ingredient suppliers and contract manufacturer to ensure that your ideas successfully transition from conception to commercial reality.
What we can do for you:
New Concept Identification
- Fresh concept ideas
- Identify ingredients and suppliers
- Sense-check your concepts
- Assistance in defining your concept for efficient product development
- Development of evidence-based formulations by degree qualified nutritionists and naturopaths
- Recommended permitted indications (therapeutic claims) and marketing claims
- Raw material evaluation
- Claim substantiation packages
- Full regulatory evaluation for suitability
- Assessment of product viability (dosage forms, costs, batch size)
- Guidance on product development timeline
- Direct & manage stakeholders
- Identification of suitable contract manufacturers
- Management of tender process
- Manage pilot trials
- TGA listing applications
- Writing or review of technical or marketing collateral
- Product label preparation or review
- Design protocols for stability trials
- Coordinate and review QC / GMP documentation
- Review advertising
If you’ve got an idea, for either a complementary medicine or food product that you want to explore, then we can help you. Talk to us today:
Cosmetics, personal care and household products
In Australia, cosmetics do not have to be submitted to any government agency before they are supplied. However there are some regulatory requirements that must be met. The individual ingredients must be listed on the Australian Inventory of Industrial Chemicals (the Inventory) https://www.industrialchemicals.gov.au/search-inventory and must not be subject to a poisons schedule; labelling and packaging must comply with various standards for labels, weights and measures; and claims made must be cosmetic claims, not medical or therapeutic claims.
NOTE: Primary sunscreens, except tinted products, having a claimed SPF of greater than 15 require listing as a 'Medicine' on the Australian Register of Therapeutic Goods (ARTG).
What we can do for you:
- Undertake Inventory searches for ingredient inclusions
- Provide guidance on categorising your chemical
- Prepare and submit applications to the Australian Industrial Chemicals Introduction Scheme (AICIS) for inclusion in the Inventory
Advice on restrictions
- Check all your ingredients against the Poisons Schedule and advise on limits if applicable
- Advise on labelling and packaging requirements
- Review and prepare product claims
- Ensure all marketing materials are compliant with regulations
Australian Industrial Chemicals Introduction Scheme (AICIS) liaison
- Create company registration and annual declarations
- Submit specific information requirement requests
- Submit search requests for the confidential section of the Inventory
View our Cosmetics video
How we provide our expert advice to you
Call or email us anytime to discuss your product and marketing goals. This will help us decide on what are the best options for you to ensure your products are not only compliant with Australian regulations, but also create the biggest impact in the marketplace.
Our comprehensive reply to your first email or phone call will be sent at no charge. If you choose to proceed we will send you our Client Agreement.
Our highly experienced technical team, with credentials in science, botanic medicine, drug development, chemistry and human nutrition will work on your project. We can help you with your dealings with government regulatory agencies, manufacturers, advertising agents and any other relevant parties
Contact us now to discuss your ideas.
Robert Forbes & Associates is now trading as RFA Regulatory Affairs
The Management Team
Founder and Managing Director
Robert has been in the health industry since 1980, when he developed and distributed complementary medicines for pharmacies and practitioner clinics. As Australian regulations evolved and the Therapeutic Goods Regulations were introduced in the late 1980s, he switched his focus to consulting on the new compliance obligations facing the industry.
He is an active and long term member of numerous professional and industry associations and has spoken at conferences in Australia, China, New Zealand and the USA, and sat on many regulatory policy committees.
Robert’s personal interest is music creation and production and he plays keyboards. Enjoy at www.tramtracks.com.
BMedSc, BHSc (Chinese Med), MHerbMed (Hons)
Regulatory Affairs Manager
Ellie Kim joined RFA Regulatory Affairs in 2012 and is now Regulatory Affairs Manager. She has managed a wide variety of projects for varying business sizes, including many major Australian and international brands within the cosmetic, complementary medicine and food industries.
Ellie is bi-lingual in English as well as Korean and has represented RFA Regulatory Affairs at trade fairs and conferences both domestically and internationally. Ellie manages the regulatory team and is also a key presenter of RFA’s popular training courses.
BA (Hons), BHSc (Naturopathy), Dip Western HerbMed, Dip Nutrition
Kate joined the team in September 2007 and is our Training Manager and a Senior Regulatory Affairs Associate. Prior to RFA Regulatory Affairs, she worked extensively in project management for several major financial services companies in both New Zealand and the United Kingdom. She managed both small and large scale projects ranging from change management to the creation of governance processes for corporate wide project management.
Kate moved to Sydney from London and furthered her studies in the health disciplines and has worked in a range of positions within the complementary medicine and cosmetic industries.
Kate’s wide-ranging experience and presentation skills make her an interesting and approachable speaker, with plenty of information to impart via our popular on-line training courses.
Technical and administration
The QA manager of our technical team ensures advice is cross-checked internally before been sent to you. We also have a network of associates we regularly work with who provide GMP advice to manufacturers, assist with medical device applications and advise on international regulatory requirements. Our administration team helps keep the business running smoothly and manages your billing account.