Greetings from Freyr Australia
Freyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey. At Freyr Australia, we support companies to register their products with the TGA, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete TGA registration life cycle.
Industries We Serve
Australia is one of the emerging global markets for pharmaceutical products. For distribution or marketing of medicinal products or drugs in Australia, manufacturers must obtain approval from the Therapeutic Goods Administration (TGA), the body responsible for enabling pharmaceutical products registration in Australia. With the recent development in mandates pertaining to labeling and submission formats, it is necessary for manufacturers/sponsors to keep abreast with the TGA regulations.
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Medical Devices in Australia are regulated by Therapeutic Goods Administration (TGA). The Medical Devices and IVDs shall be listed in Australian Register of Therapeutic Goods (ARTG), they are marketed in Australia. Manufacturers must appoint an Australia TGA sponsor for registering their device. Freyr has successfully helped multiple medical device companies with the Australia TGA Medical Device Registration process
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Food and Food Supplements is the largest manufacturing industry in Australia. The industry is very dynamic and gives paramount importance to the quality and safety of food products manufactured in and/or imported to Australia. Therefore, to ensure compliant market entry, manufacturers or importers must follow the Food Standards Code of Australia, especially in the aspects of ingredient safety, labeling and claims.
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The growing interest in personal care and increasing disposable incomes set the market growth of cosmetics in Australia on high. Cosmetics in Australia are classified as industrial chemicals and are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) as per the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act). If the product’s primary function is sunscreen, then such product is regulated under Therapeutic Goods and Administration (TGA).
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Freyr Digital
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence Know More
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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About Freyr
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Support, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.
Know MoreOur Regional Expertise
We are a global firm and we have local expertise across the following countries.
