Sue Akeroyd & associates
Regulatory Consultants to the Health, Personal and Home Care Industries
Regulatory Strategist and Red Tape Navigator
What We Do
Understanding the pre-market and post-market regulatory requirements for health, personal and home care products can be challenging. Some products cross several regulators and multiple regulations, so it can be a difficult, time consuming, and error prone process without professional help.
At Sue Akeroyd & Associates we specialise in the regulatory requirements of medicines, including over the counter (OTC) medicines, complementary medicines, as well as medical devices; and their respective boundary products such as cosmetics, dietary supplements, and foods.
We work with, for example, the Therapeutic Goods Administration (TGA), and the Australian Industrial Chemicals Introduction Scheme (AICIS) which is the gateway for introducing chemical substances to Australia – including for cosmetics. In particular we maintain close contact and involvement with the peak trade bodies representing the respective industry sectors.
Regulatory Consultants You Can Rely On
Why Choose Sue Akeroyd & Associates?
In Australia, health, personal and home care products are variously regulated, by multiple authorities and rules. Offshore status is not always a prediction of Australian status. That’s where Sue Akeroyd & Associates can help. We have the breadth of knowledge and connections to guide you through Australia’s potentially complicated regulatory processes. We have been in business since 1989 and have an extensive track record of success – including complex projects. In addition, we have received numerous awards. This includes the Complementary Medicines Australia (CMA) Lady Cilento Award as well as the Consumer Healthcare Product Australia (CHP) Award for Excellence.
We pride ourselves on a personalised and mentoring approach, where communication is the key. Over time we have developed valuable and effective relationships at the highest decision-making levels of government, professional and ethical associations.
These are just some of the reasons why people trust us when they need a regulatory consultant to help them navigate the ‘red tape’.
The Over-the-Counter (OTC) medicine market is one of the most dynamic parts of the healthcare market. They are medicines that do not need a prescription. Some can be bought at supermarkets but others at pharmacies only.
The popularity of complementary medicines has grown significantly in recent years. They can include vitamins as well as traditional herbal medicines. They can be purchased from health food shops, supermarkets and pharmacies.
Medical devices cover a broad range of apparatus and applications, from diagnosis and monitoring of conditions through to control of conception. The range of apparatus includes medical gloves, facemasks, bandages, x-ray machines and blood pressure monitors.
This is a complexly regulated industry, variously being controlled, and globally harmonised. Ingredients in cosmetic products are classed as industrial chemicals, even when ingredients might be described as natural origin. Their status in the national chemical substance inventory is critical.
The Australian Prescription medicine market is highly regulated. It has been described as one of the most policy sensitive sectors in the Australian industry. That's why making sure applications follow appropriate protocol is essential.
Foods and Food Supplements
Bi-national standards of Australia and New Zealand cover the whole of the food supply chain, from the farm to the table, for both the food manufacturing industry and primary producers. But, food supplements are affected by the food-therapeutic interface and may be considered medicine in Australia
Product Concept Evaluation
We have years of experience across many therapeutic areas including medicines, foods, and cosmetics. With this knowledge we can evaluate your product concept before you invest time and money in the regulatory process.
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