Abdera Business Services

Abdera Business Services offers expert TGA sponsorship and company setup services for businesses looking to enter the Australian market. They provide comprehensive support for regulatory compliance and business expansion.

Abdera Business Services specializes in assisting overseas businesses with establishing a presence and navigating regulatory requirements in Australia. They offer crucial TGA sponsorship services, acting as a domestic legal entity responsible for ensuring therapeutic goods, including medicines and medical devices, comply with Australian standards and are registered on the ARTG. With extensive experience in the health and medtech sectors, Abdera streamlines the complex TGA approval process, allowing clients to focus on their core business strategies, clinical trials, and distribution. Their services extend to company setup, obtaining Australian Company Numbers (ACN) and Australian Business Numbers (ABN), and even providing a resident director for TGA sponsorship purposes. Beyond regulatory compliance, Abdera provides a suite of business support services, including accounting, virtual CFO, payroll, and HR, to facilitate seamless business operations and growth in Australia. They are committed to being a trusted partner, ensuring clients meet all legal and regulatory obligations while expanding their market reach.

About

**Who they are**
Abdera Business Services is an Australian-based provider specializing in TGA sponsorship and company setup services. They aim to be a central resource for businesses seeking to understand and navigate the Australian market.

**Expertise & scope**
* Expertise in TGA sponsorship for importing, manufacturing, or selling therapeutic goods in Australia.
* Services include acting as a domestic TGA sponsor, managing ARTG applications, and ensuring regulatory compliance.
* Assistance with company setup and understanding Australian business taxes, including GST and PAYG Withholding Tax.
* Support for businesses looking to expand into Australia, offering guidance on regulatory landscapes and business expansion.

**Reputation / proof points**
* Over 20 years of experience in the health and medtech industries.
* Based in Sydney, Australia.

Additional information

Abdera Business Services emphasizes a collaborative approach, viewing client relationships as connected partnerships. They focus on initiating systems and practices for efficiency and proactively addressing potential problems. Their services are designed to help businesses confidently expand into Australia, with a particular focus on navigating the complexities of TGA compliance for therapeutic goods and medical devices. They also provide insights into Australian taxation, including company tax, GST, and PAYG withholding, to aid in cost-effective business setup and planning.

Key Highlights

  • Over 20 years of experience in the health and medtech industries. Source
    “With over 20 years of experience in the health and medtech industries, we offer tailored TGA sponsor services”
  • Specializes in TGA sponsorship for therapeutic goods in Australia. Source
    “Abdera Business Services is here to make this process seamless. With over 20 years of experience in the health and medtech industries, we offer tailored TGA sponsor services”
  • Provides comprehensive support for company setup and doing business in Australia. Source
    “Based in Sydney, our expertise lies in Australian and international businesses looking to set up in Australia. We give you the confidence to expand into Australia.”

Certifications & Trust Signals

  • Established presence in Sydney, Australia. Source
    “Based in Sydney, our expertise lies in Australian and international businesses looking to set up in Australia.”

Buyer Snapshot

Best for
  • Overseas businesses looking to import, manufacture, or sell therapeutic goods in Australia.
  • Companies needing TGA sponsorship and regulatory compliance support.
  • International businesses seeking assistance with company setup and market entry in Australia.
How engagement typically works
  • Collaborative partnership with management teams.
  • Proactive problem-solving and system implementation.
  • Handling regulatory complexities to allow client focus on business growth.
Typical deliverables
  • TGA sponsorship services.
  • Company setup and registration.
  • Resident director services.
  • Accounting and virtual CFO services.
  • Payroll and HR support.
  • Guidance on Australian business taxes.
Good to know
  • Best when requiring specialized TGA sponsorship and Australian market entry support.

Pricing

Model: Retainer
HQ: Sydney, Australia
Languages: English
Timezones: Australia/Sydney
Status: listed

Services & Capabilities

AU TGA Sponsor Services

Jurisdictions: AU
Countries: AU
Industries: Medical devices, PPE
Portfolio: 6-25
Onboarding time: 5–30 days
Pricing model: Retainer
Starting from: AUD 4,000
Included services: Sponsor address and labeling review, Annual ARTG charge reminders and continuity planning, Change notification and variation assessment, TGA device classification and grouping
Supports Artg: Yes
Evidence Review: Yes
Australian Entity State: NSW
Recall Vigilance Support: No
Fsca Recall Support: No

Additional tga_sponsor_au Details

Supports Artg
true
Australian Entity State
NSW
Onboarding Steps
The process involves appointing a domestic TGA sponsor, which is a legal requirement for overseas businesses importing, manufacturing, or selling therapeutic goods in Australia. Abdera Business Services acts as this sponsor, handling applications to the ARTG and ensuring product quality and regulatory compliance.
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