A Leading, Global,
With Seamless Submissions
Experience Unified RIM
Australia’s Life Sciences industry covers biotechnology, pharmaceuticals, complementary medicines, medical technology (devices and diagnostics), and food and food supplements. In a view to align with international safety and Regulatory standards, the current Regulatory framework in Australia, though stringent enough, is set for major face lift in coming years challenging market entrants to navigate their operations.
With in-depth Regulatory knowledge, Freyr offers a comprehensive set of Regulatory services aimed at assisting Life Sciences organizations to streamline operations and thus to achieve regional compliance. Freyr provides Regulatory services for Australia for every life science industry inclusive of:
industries we serve
Australia is one among 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 governing drug registrations and approvals in the country. 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.
Freyr’s experts evaluate submission data accuracy against TGA regulations to ensure compliance in all stages and, thus, enable accurate submissions for quick health authority reviews and approvals. Freyr supports medicinal product Regulatory submissions, which includes assistance in registration via different pathways (150 WD and 220 WD) based on product type. We also provide post-approval support for license renewals, dossier updates and life cycle management
- Regulatory Consulting
- Regulatory Affairs
- Publishing and Submissions
- Medical writing
- Compliance, Audit and Validation
- Regulatory Labeling
- Regulatory Artwork
Generic and Innovator drugs bear many similarities, except the pricing. A Generic drug has the same dosage, safety, effectiveness, strength, stability, quality and performance characteristics as an innovator drug. It is also consumed in a manner similar to an Innovator drug. solutions as an option to Innovator drugs.
Biological medicinal products are promising solutions in the prevention and treatment of several life-threatening, chronic diseases and health conditions that cannot be managed with the help of normal pharmaceutical products.
The medical device market in Australia is well developed with a systematically defined Regulatory system. A major share of the medical devices used in Australia are imported and the rest are manufactured by renowned global companies. The Therapeutic Goods Administration (TGA) governs the medical devices regulation in Australia. Under the purview of TGA, the Australian Regulatory Guidelines for Medical Devices (ARGMD) is established, which is said to be similar in line with the European Union regulations.
To enable medical devices manufacturers, gain an easy Australian market access, Freyr with its strong local presence caters to various Regulatory requirements. In Australia, Freyr provides Regulatory support for the following types of medical devices:
- Medical devices (Class I, Class IIa, Class IIb, Class III)
- In-vitro Diagnostic Devices
- Combination Products
- New Devices (Novel devices)
- Regulatory Strategy and Approach
- Regulatory Market Intelligence
- Medical Device Registration and Approval
- Quality Management System (QMS) Compliance
- TGA sponsor representative services
- Medical Device Vigilance
- Pre-market Submissions
- Translational Services
- One-stop shop for all medical device Regulatory consultation
- On-time submission with quick turnaround time
- Cost-effective approach
- Proven track record of successful device registrations and submissions
- Strategic and well-versed local Regulatory knowledgebase
Food and Food Supplements
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.
The key point of consideration here is that Australia has no category of food products called ‘dietary supplements.’ Instead, they are regulated as Complementary Medicines in Australia. To streamline applicants’ market-entry efforts, Freyr with a strong regional presence, offers Regulatory support for both Food Products and Complementary Medicines as well.
- Regulatory and Technical Advice
- Regulatory Submissions, Labeling and Product Reviews of Complementary Medicines and (or) Dietary Supplements (general and wholistic foods, formulated supplementary sports foods, electrolyte drinks and drink bases, formulated meal replacements, formulated supplementary foods, formulated beverages Formulated caffeinated beverages)
- Review of Existing Product Formulation Data and Ingredients for Inclusion on Listable Substances Database
- Advice on the Eligibility of Ingredients and Finished Products along with the Level of Registration Required in Australia
- Food/Complementary Medicine Product Label Review
- Novel Food Enquiry Submission
- Product Listing on the Australian Register of Therapeutic Goods (ARTG) or Change of the Recipient of Product after Listing on the ARTG
- Review or Prepare Nutrition Information Requirements (NIP)
- Determination of the Promotional Material for the Finished Product, including Websites, Labeling and Packaging, and in Media Advertising
- Gap Analysis to Determine if Sufficient Sata Exists to Support a Health Claim
- Qualified Regulatory experts in relevant disciplines including chemistry, herbal medicine, human nutrition and food science
- Efficient, flexible and tailor-made solutions to meet clients’ specific Regulatory needs
Growing interest for personal care and increasing disposable incomes set the market growth of cosmetics in Australia on high. Cosmetics in Australia are classified as the 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).
The cosmetic market in Australia is driven by innovation which demands manufacturers to align with current trends. Lack of such knowledge may prove challenging while trying to gain market lead. Any deviation from approved ingredient list and formulation techniques might result in rework and product cancellation in some cases, both of which will affect the brand value and revenue.
Freyr supports market entrants to understand existing Regulatory trends and to develop and market their products in line with country’s compliance requirements. Freyr assists in comprehensive ingredient analysis to make sure the product is made up of only listed and allowed ingredients.
- Product Classification
- Ingredient Analysis
- Regulatory Intelligence
- Label Assessment
- Claims Review
- End-to-end cosmetic Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of cosmetic products like skin care, hair care, infant care, oral care, beauty products, etc.
- Support for region-specific Regulatory complexities
- Extensive partner network across the globe
- Strong relationship with different health authorities
- Structured and cost-effective approach to ensure speed to market for the cosmetic products
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
Freyr rDMS is an end-to-end electronic Regulatory Document Management System (rDMS/eDMS) exclusively designed to enable Regulatory data and documents in a compliant, efficient and intuitive manner.
Freyr Label 360 The Real-time is Now REAL Content To Carton
Freyr PRISM is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
More Products from Freyr Click Here