New Update

Regulatory Support for TGA eCTD Submissions

Starting November 01, 2021, the Therapeutic Goods Administration (TGA) will begin a phased transition to Electronic Common Technical Document-only (eCTD-only) for all prescription medicines.

Know More

Freyr Expertise

  • End-to-end Pharmaceutical Product Registration
  • Authorized Local Representation
  • TGA Manufacturing Site Registration
  • Market entry strategy and Market access intelligence
  • Act as QPPV (Qualified Person responsible for Pharmacovigilance)
  • Query Support Management till Approval
  • Pharmaceutical Lifecycle Management Support
  • Ad-hoc Regulatory Affairs Consultation
Know More

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.

Know More

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

Know More
Medical Device

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.

Know More
Food and Food Supplements

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).

Know More

Freyr Digital

Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
Know More


An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
Know More


Freyr iReady

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.
Know More


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 More

Our Regional Expertise

We are a global firm and we have local expertise across the following countries.


903/50 Clarence St,
Sydney NSW 2000,
(9th level of building 50),

Quick Inquiry