Freyr Solutions Australia

Freyr Solutions Australia is a leading regulatory consulting firm specializing in TGA submissions and market access for life sciences companies. They offer end-to-end support for medicinal products, medical devices, and food supplements.

Freyr Solutions Australia is a premier regulatory consulting firm dedicated to assisting life sciences companies navigate the complexities of the Australian market. With a strong focus on Therapeutic Goods Administration (TGA) regulations, they provide comprehensive services for product registration and market authorization. Their expertise spans medicinal products, medical devices, and food supplements, offering tailored solutions for each category. Freyr Australia helps clients with TGA eCTD submissions, regulatory strategy, market intelligence, in-country representation, and post-market surveillance functions. They also provide next-generation regulatory software solutions to streamline the entire TGA registration lifecycle. Leveraging their deep understanding of TGA requirements and extensive experience, Freyr Solutions Australia acts as a crucial partner for companies seeking to register and distribute their products in Australia. They ensure smooth review and approval processes, facilitating timely market entry and compliance with evolving regulations.

About

**Who they are**
Freyr Solutions Australia is a regulatory consulting firm specializing in TGA submissions and market access for life sciences companies. They offer end-to-end support for medicinal products, medical devices, and food supplements.

**Expertise & scope**
* TGA Marketing Authorization Application (MAA) submissions for pharmaceutical products.
* Registration and market access support for the Australian Register of Therapeutic Goods (ARTG).
* Assistance with legal and administrative requirements, including communication with the TGA.
* Support for medicinal products, medical devices, and food supplements.
* Global regulatory solutions and services provider.

**Reputation / proof points**
* Commenced operations in the United States in 2011 with a small team.
* Developed the AI-first regulatory platform, freya fusion, grounded in over 15 years of regulatory expertise.
* Offices and contact points in Australia, with regional delivery centers and offices in the USA, UK, EU, and India.

Additional information

Freyr Solutions Australia provides comprehensive support for navigating the Therapeutic Goods Administration (TGA) requirements for market entry in Australia. Their expertise in handling Marketing Authorization Application (MAA) submissions is critical for successful product registration and timely market access. They assist manufacturers and MAA holders with managing regulatory and administrative processes, ensuring smooth communication with the TGA. This includes in-depth understanding of TGA practices and requirements for various pharmaceutical products, medical devices, and food supplements.

Key Highlights

  • Specializes in TGA Marketing Authorization Application (MAA) submissions for pharmaceutical products. Source
    “Freyr, as a proven Regulatory partner, assists pharmaceutical manufacturers/MAA holders to manage the legal and administrative requirements along with communications with the TGA.”
  • Offers end-to-end support for medicinal products, medical devices, and food supplements. Source
    “Freyr Solutions Australia is a leading regulatory consulting firm specializing in TGA submissions and market access for life sciences companies.”
  • Provides registration support for market access to Australia via the ARTG. Source
    “Freyr provides registration support which allows the MAA holders/manufacturers to access the Australia market with the registration and distribution of their pharmaceutical products.”
  • Utilizes an AI-first regulatory platform, 'freya fusion', for compliance needs. Source
    “freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs.”

Certifications & Trust Signals

  • Established operations in the United States in 2011. Source
    “Commenced operations in the United States (US) with a small set-up and a 5-member core team.”
  • Maintains a presence with offices and contact points in Australia, USA, UK, EU, and India. Source
    “With Regional Delivery Centers, Client Servicing Centers andOffices in USA, UK, EUand India”

Buyer Snapshot

Best for
  • Life sciences companies seeking TGA market access
  • Manufacturers requiring assistance with MAA submissions
  • Businesses needing regulatory strategy and lifecycle management
How engagement typically works
  • End-to-end regulatory support
  • Partnership for TGA communications
  • Leveraging AI-driven platforms for compliance
Typical deliverables
  • TGA MAA submission packages
  • ARTG registration support
  • Regulatory strategy documents
  • Lifecycle management plans
Good to know
  • Best when requiring specialized knowledge of Australian TGA regulations.
HQ: Sydney, Australia
Languages: English
Timezones: Australia/Sydney
Status: listed

Services & Capabilities

AU TGA Sponsor Services

Jurisdictions: AU
Countries: AU
Industries: Medical devices, Dental
Portfolio: 100+
Onboarding time: 7–30 days
Pricing model: Retainer
Starting from: AUD 9,000
Included services: Annual ARTG charge reminders and continuity planning, eBusiness Services account setup support, Post-market vigilance support and incident reporting workflow, Conformity assessment evidence mapping (EU/UK/US/CA)
Supports Artg: Yes
Device Classes Supported: IVD
Evidence Review: Yes
Australian Entity State: Australia

Additional tga_sponsor_au Details

Supports Artg
Yes
Device Classes Supported
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Recall Vigilance Support
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Australian Entity State
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Onboarding Steps
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