Your Partner in Natural Product Commercialisation
From Idea to Market-Ready we turn your concept into a compliant, successful product. Our regulatory advisory services help you achieve and maintain compliance.
Natural Product Development & Advisory Specialists
Specialising in Australian Listed Medicines & Foods with linked health claims, we guide you through every stage – from concept to regulatory approval to launch, reducing risk, saving time, and ensuring compliance every step of the way.
Natural Product Development
Tried and tested processes can capture your ideas – to effectively develop and commercialise products. We have over 60 years combined experience in product development.
Regulatory and Technical Advisory
We support clients with clear, reliable and pragmatic advice on a wide range of technical and regulatory compliance matters. Our approach seeks to turn regulatory challenges into tangible solutions.
Connected with raw material suppliers, manufacturers, industry and regulatory bodies. We regularly attend leading industry tradeshows, seminars and events. We strive to be at the forefront of innovation, trends and science
Regulatory & Technical evaluation & advice for products developed within TGA and FSANZ frameworks. We have trusted regulatory partners for any specialised regulatory needs – giving you peace of mind and advice you can trust
A customised approach to suit your needs. We can project manage from concept to launch, or switch-on switch-off to provide expertise only where and when you need it. We work with diverse brands – big & small – established & newcomers
Our Services
Full service Natural Product Development or Regulatory and Technical Advisory. We have you covered!
Natural Product Development
From concept to launch, we handle it all!
New Concept Identification
- Fresh concept ideas
- New ingredients
- Sense-check your concept
- Gap analysis
- Regulatory strategy
Product Design
- Active formulation design
- Raw material selection
- Active load viability
- Claims advice
- Value proposition
- Expert’s eye
Technical Feasibility
- Regulatory compliance
- Dosage form
- Claims substantiation
- Stability / Shelf Life
- Commercial viability (COGs & MOQ)
- Manufacturing partners
Project Management
- Timeline management
- Direct & manage stakeholders
- Manufacturing tender
- Regulatory & Technical dossiers
Manufacturing & Launch
- TGA Listing applications
- FSANZ health claim notifications
- Label compliance advice
- Advertising compliance advice
- Writing – technical & marketing materials
Regulatory and Technical Advisory
We support clients with clear, reliable and pragmatic advice. Our approach seeks to turn regulatory challenges into tangible solutions. Practical and succinct advice is always underpinned by deep experience and Australian law citations to educate our clients and elevate compliance knowledge with confidence.
Listed Complementary Medicines
- Formulation regulatory reviews
- Ingredient regulatory reviews
- Specification reviews
- Raw material evaluation
- Raw material sourcing
- TGA listing applications
- GMP Clearance applications
- Evidence packages to substantiate therapeutic and marketing claims
- Label reviews
- Advertising reviews
- Liaising with regulators for advocacy and resolutions
Food Products
- Formulation regulatory reviews
- Advice on suitable food standard
- Ingredient regulatory reviews
- Specification reviews
- Raw material evaluation
- Raw material sourcing
- Advice on permitted health, nutrition & related claims
- FSANZ health claim notifications
- Evidence packages to substantiate health and marketing claims
- Label reviews
- Advertising reviews
Cosmetic Products
- Formulation regulatory reviews
- Ingredient regulatory reviews
- AICIS categorisation
- AICIS annual submission reporting
- Label reviews
- Advertising reviews
Our Product Development Process
We have over 60 years combined experience in product development.
STAGE 0
Discuss your ideas and how NPC can help you
COST: Free of charge
GATE 1: Sign Agreement
INITIATE
STAGE 1
Define your idea and wish list using NPC’s Project Brief
- Sense-check concept
- Target claims
- Value proposition
- Regulatory classification
- Dosage form
- Target customer
- Market insights
- Commercial targets
- Competitive advantage
GATE 2: Sign Project Brief
DEFINE
2 weeks
STAGE 2
Research and development activities to design your Active Formula
- Literature review
- Claim substantiation
- Ingredient dosages & preparations
- Stability review
- Supplier sourcing & tender
- Active load viability
- Commercial viability
- Regulatory compliance
- Manufacturing viability
GATE 3: Sign Active Formula
EXPLORE
6-8 weeks
STAGE 3
Manufacturing transfer for Final Formula design
- Manufacturing tender
- Excipient selection (non-actives)
- Formula refinement
- Pilot / bench trial
- Sample approval
- Specifications
- Stability protocol
- Evidence package
- Regulatory & Technical dossiers
GATE 4: Sign Specification
DEVELOP
10-16 weeks
STAGE 4
Commercialisation activities for Product Launch
- TGA listing application
- FSANZ health claim notifications
- Label reviews
- Advertising reviews
- Education/ writing
- Team training
Product Launch
DELIVER
16 weeks
Our Team
We have curated a team of deeply experienced consultants to offer clients diverse yet specialised advice.
Credentials and experience of our team include – Naturopath, Nutritionist, Herbal Medicine, Biochemist, Health Scientist, Product development, Education, Clinical Practice, Regulatory Affairs. All members of the NPC team have a science degree.
Abbie Harris
Founder, Director and Principal Consultant
Abbie is a seasoned product developer, formulator and project manager. She has held management positions in small and large healthcare companies, leading product development teams to launch complementary medicines and foods across many dosage forms, health categories, markets and regulatory systems.
In 2015 Abbie founded NPC, a consulting company specialising in the development and commercialisation of complementary medicines, foods and other healthcare products. NPC has nurtured an international client base, helping brands with all aspects of product development as well as regulatory affairs, training and technical writing.
Abbie is an active member of the industry. She attends leading international trade shows, education events and seminars and for several years contributed to the Regulatory Technical Committee within CMA – Australia’s peak industry body.
Leanne McCauley
Senior Consultant & Medicine Advertising Specialist
With over nine years of experience in advertising compliance at the Therapeutic Goods Administration (TGA), Leanne brings unparalleled expertise in navigating the advertising regulatory landscape for medicines and medical devices. Since leaving the TGA, Leanne has focussed on supporting advertisers with independent, clear, reliable and pragmatic advice on developing and amending advertising to comply with the advertising laws.
Through her work with NPC, Leanne has extended her advisory skills to provide label compliance reviews for listed medicines, the development and review of evidence packages and advice on selecting an appropriate regulatory framework for products at the interface of complementary medicines and foods.
Growing up in her family’s pharmacy, Leanne developed a strong appreciation for the dedication required to run a small business and a deep understanding of consumer vulnerabilities. She draws on these experiences, along with her biochemistry degree, to help sponsors and advertisers navigate regulatory challenges with confidence and compliance.
Chinthani Wijayapala
Senior Consultant (Cosmetics, Foods, Listed medicines)
Chinthani has over 15 years’ experience within the Australian complementary medicines industry specialising in regulatory affairs, new product development, marketing and compliance. Having worked at leading manufacturers, brands and raw material suppliers, she has an array of knowledge ranging from initial formulation development to the compliant manufacturing of finished products.
An esteemed member of the NPC team, Chinthani supports clients with vast consultancy services in regulatory affairs, inclusive of complementary medicines, nutritional supplements, foods and cosmetics. Through her work in regulatory affairs and new product development, Chinthani has assisted numerous brands successfully bring products onto the Australian market, supporting them from innovation to new product launch.
Chinthani is also a training specialist with Regulatory Training Direct.
Sandra Kreitschmann
Senior Consultant & Claim Substantiation Specialist
With over 30 years’ experience in the health & wellness industry, Sandra is a passionate degree-qualified complementary medicine professional.
Originally from Germany, Sandra studied Naturopathy in Brisbane, followed by postgraduate studies in health science, higher education and public health. She has worked with major Australian brands and colleges and is experienced in lecturing, health writing, research and development, and regulatory affairs.
Sandra had dedicated the last 15 years of her career to mastering evidence packages that robustly substantiate therapeutic indications and marketing claims; and assists in ideation and literature reviews during the early stages of product development. Honing her research, critical appraisal and regulatory skills Sandra excels in this complex area of complementary medicine compliance.
Sandra has been working with NPC since January 2017.
Daniella Bravin
Senior Consultant (Listed Medicines, Foods, Cosmetics & Medical Devices)
Daniella is a regulatory affairs specialist with over 15 years’ experience in the health and wellness industry. She supports the development and global launch of complementary medicines, export-only medicines, cosmetics, skincare and wellness products, with expertise across regulatory frameworks including TGA, FSANZ and AICIS. Daniella works with brands to navigate compliance requirements and achieve efficient market access across Australia, New Zealand, Asia, the United States and Europe.
She has held senior regulatory and technical roles across industry, managing ingredient compliance and regulatory strategy for new product development and product launches. Daniella works closely with clients to align regulatory requirements with commercial objectives and support compliant product innovation.
Originally trained and practising as a naturopath, Daniella brings a clinical perspective to regulatory strategy and product development, helping bridge the gap between regulatory requirements, formulation considerations and consumer health outcomes.
Partner Services
Regulatory Training Direct
Your Training Partner
Regulatory Training Direct provides online training for the Health Products industry. Our expert trainers have over 100 years of combined experience in various aspects of regulatory affairs.
Our training courses have been developed to provide up-to-date and easy to understand information on the regulatory requirements for listed complementary medicines, dietary supplements, food products and cosmetics.
We understand the complexities and major pitfalls and can teach you how to navigate the regulatory framework to help develop and maintain compliant products in the market.
Courses cover regulations in Australia, New Zealand and the USA.
Client Feedback
See why professionals choose us for their product and compliance needs.
I’ve always found NPC to be professional, reliable, and extremely knowledgeable in their field. Your team consistently delivers high-quality work, communicates clearly, and approaches projects with a practical, solutions-focused mindset. It’s been a pleasure working with you, and I wouldn’t hesitate to recommend NPC to others looking for a trusted partner.
Working with NPC has brought clarity and structure to what can otherwise be a very complex regulatory landscape. Your guidance has been thoughtful, commercially aware, and firmly grounded in compliance. I’ve particularly appreciated the balance between innovation and regulatory discipline — ensuring we build something strong and defensible from the outset. For founders navigating the listed-medicine pathway in Australia, that level of rigour is invaluable.
I have worked with NPC across both large and small projects and have always been impressed with their depth of expertise and professionalism. From TGA listing support to ingredient and regulatory reviews, the team consistently provides clear guidance and practical solutions. Their knowledge of compliance and product development has been invaluable in helping us navigate complex requirements and bring products to market with confidence. I would highly recommend NPC to any business seeking expert regulatory and commercialisation support.
NPC formulated our first complementary medicine, Lipiforte. From the beginning, Abbie professionally translated my formula from its conception in my mind into a physical TGA-approved product. She directed and oversaw the entire regulatory process and manufacture, ensuring every step was compliant, including the label. I couldn’t have produced such a high-quality product without Abbie liaising with all the relevant bodies on my behalf every step of the way. I won’t ever look elsewhere for my next one. Thank you NPC.
Abbie and her team NPC are incredibly knowledgeable and thorough, and is a team we trust implicitly when navigating the complementary medicine regulatory environment. They approach every project with professionalism, clarity and efficiency, ensuring work is delivered accurately and on time. NPC is honest, communicative and genuinely committed to achieving the best outcome for their clients. NPC is a pleasure to collaborate with and a trusted partner in our work.
From the 1990s I managed RFA Regulatory Affairs, which was, at that time, Australia’s largest regulatory consultancy specialising in complementary medicines, foods and cosmetics. We had at one stage over 15 regulatory specialists; but when it became critical to comply with the TGA’s requirements for compiling evidence to support indications for use, there was only one person I could trust to do this work for us. It was Abbie of course. When I sold the business after over 30 years, I was privileged to able to partner with Abbie in our training business Regulatory Training Direct.
Abbie is an absolute delight to work with and her regulatory expertise is exemplary. She consistently brings clarity and confidence to complex compliance matters, ensuring that every detail is addressed with precision and care. Her proactive approach, combined with a deep understanding of evolving regulations, makes her an invaluable partner in navigating challenging environments. Beyond her technical skills, Abbie’s collaborative nature and positive attitude make working with her both seamless and genuinely enjoyable.
Get in touch
Email: info@npcentre.co
PO Box 277, Kiama, NSW 2533 Australia
