Services

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

Product Design  

  • 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)

Project Management  

  • Guidance on product development timeline
  • Direct & manage stakeholders
  • Identification of suitable contract manufacturers
  • Management of tender process
  • Manage pilot trials

Regulatory Support

  • 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:

T: +61 2 9660 8027       E: This email address is being protected from spambots. You need JavaScript enabled to view it.

Please note that Australia does not have a product category called 'Dietary Supplements'. Most (but not all) products classified as 'Dietary Supplements' in some countries are regulated in Australia as 'Complementary medicines'.

View our Complementary and OTC Medicines page here

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 Chemical Substances (AICS) www.nicnas.gov.au 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 colour fade 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:

Ingredient assessment

  • Undertake AICS searches for ingredient inclusions
  • Apply for an AICS exemption when and if required
  • Carry out applications to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) for inclusion in the AICS

Advice on restrictions

  • Check all your ingredients against the Poisons Schedule, or for quarantine or import issues
  • AQIS ingredient reviews and permit applications

Marketing requirements

  • Advise on labelling and packaging requirements
  • Review and prepare product claims
  • Ensure all marketing materials are compliant with regulations

National Industrial Chemicals Notification and Assessment Scheme (NICNAS) liaison

  • Create company registration and annual reports
  • Prepare and submit Form 15 (including MSDS

View our Cosmetics video

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.

Flow chart

  • The preliminary discussions and emails are given free of charge
  • Once you are confident and feel fully informed you will be asked to sign our Client Agreement and pay your deposit as an advance against work we are about to do on your behalf
  • Only when you instruct us in writing and we have received the deposit, will we then begin to work on your particular project
  • Our technical team, comprised of highly experienced researchers with credentials in science, botanic medicine, drug development, human nutrition and marketing will work on your project. Our in-house processes have been developed over twenty years and we are constantly keeping up to date with the latest changes in Australian & New Zealand Government regulations. Throughout the life of your project, we will be liaising with you about any fine tuning of your requirements. We also act as a bridge between you, and government agencies, manufacturers, attorneys, advertising agents and any other relevant parties
  • As we work on your project, rest assured that you will only receive advice from us that has been compiled by experts and double checked by our managers, before being issued to you
  • The final product can then be supplied with confidence.

The time taken for this entire process, from initial conversation to putting your final product on the shelf, can vary from several weeks to several months. This will depend on the complexity of your project, the nature of any claims, the availability of ingredients, alterations to the initial instructions, accuracy of the information that you supply to us and other such variables.

Due to these considerations costs can also vary. We will offer you suggestions as to how to minimise our time on your project and thus keep your costs down.

 

Contact us now to discuss your ideas.

 

Robert Forbes & Associates is now trading as RFA Regulatory Affairs

robertforbesprofileRobert Forbes

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.

E: This email address is being protected from spambots. You need JavaScript enabled to view it.

linkedin

 

elliekimprofileEllie Kim

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.

E: This email address is being protected from spambots. You need JavaScript enabled to view it.

  

katedureyprofile

Kate Durey

BA (Hons), BHSc (Naturopathy), Dip Western HerbMed, Dip Nutrition

Training Manager

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.

E: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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.

 

Vitamin A    
retinol (all-(E)-retinol) mg IU
mg mg RE
IU mcg
mcg RE mcg
retinyl acetate (all-(E)-retinol acetate) mg IU
mg mcg RE
IU mcg
mcg RE mcg
retinyl palmitate (all-(E)-retinol palmitate) mg IU
mg mcg RE
IU mcg
mcg RE mcg
betacarotene mcg mcg RE
mcg RE mcg
Vitamin B    
thiamine hydrochloride mg mg thiamine (vit B1)
(USA/FDA conversion): thiamine hydrochloride mg mg thiamine (vit B1)
thiamine nitrate mg mg thiamine (vit B1)
riboflavine sodium phosphate mg mg riboflavine (vit B2)
Calcium pantothenate mg mg pantothenic acid (vit B5)
    mg Calcium
dexpanthenol mg mg pantothenic acid (vit B5)
pyridoxal 5-phosphate mg mg pyridoxine (vit B6)
pyridoxine hydrochloride mg mg pyridoxine (vit B6)
Vitamin C    
ascorbyl palmitate mg mg ascorbic acid (vit C)
calcium ascorbate(dihydrate) mg mg ascorbic acid (vit C)
    mg calcium
sodium ascorbate mg mg ascorbic acid (vit C)
    mg sodium
Vitamin D    
cholecalciferol mcg IU vit D3
IU mcg
ergocalciferol mcg IU vit D2
IU mcg
Vitamin E    
d-alpha-Tocopherol mg IU
IU mcg
dl-alpha-Tocopherol mg IU
IU mcg
d-alpha-Tocopheryl acetate mg IU
IU mcg
dl-alpha-Tocopheryl acetate mg IU
d-alpha-Tocopheryl acid succinate mg IU
IU mcg
dl-alpha-Tocopheryl acid succinate mg IU
IU mg

IU: International Units; RE: Retinol Equivalents; mg: milligrams; mcg: micrograms

Disclaimer: Whilst Robert Forbes & Associates has made every effort to be accurate, errors may appear and are inadvertent.

Services

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…

Readmore..

Dietary supplements

Please note that Australia does not have a product category called 'Dietary Supplements'. Most (but not all) products classified as 'Dietary Supplements' in some countries are regulated in Australia as…

Readmore..

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…

Readmore..

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…

Readmore..

The Management Team

Robert Forbes 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…

Readmore..

Foods

In Australia, foods do not have to be submitted to any government agency before they are supplied. However, they must still comply with the relevant standard of the Food Standards…

Readmore..

Complementary Medicines

In Australia, the Therapeutic Goods Administration (TGA) regulates therapeutic products; including medical devices, and prescription and OTC medicines including complementary medicines (for example herbs, vitamins and nutritional supplements). 'Dietary Supplements'…

Readmore..

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