Regulatory Services Australia (RSA)
The Weringa Group Pty Ltd t/a Regulatory Services Australia
Regulatory Services Australia (RSA) is an AICIS, APVMA, and TGA registered agent and Medsafe New Zealand sponsor. They offer business and distribution services to help companies operate in Australia and New Zealand.
Regulatory Services Australia (RSA), operating as The Weringa Group Pty Ltd, is a specialized agency facilitating market entry and operations within Australia and New Zealand. They are officially recognized as an AICIS Agent, an APVMA Nominated Agent, and a TGA Sponsor, demonstrating their expertise in navigating regulatory landscapes. Additionally, RSA serves as a Medsafe New Zealand sponsor, further broadening their scope of services. RSA provides comprehensive business and distribution services, leveraging long-standing relationships with government agencies in Australia and overseas. Their team is equipped to assist clients with various aspects of market access, ensuring compliance and efficient operations. The company also highlights its extensive partner network, which can be a valuable asset for businesses seeking to establish or expand their presence in these regions. With offices in Sydney, Australia, and Auckland, New Zealand, RSA offers localized support and expertise. Their commitment is to help clients successfully do business in these key markets, backed by a professional team and a deep understanding of the regulatory environments.
About
**Who they are**
Regulatory Services Australia (RSA) is a registered agent for AICIS, APVMA, and TGA in Australia, and a Medsafe New Zealand sponsor. They specialize in providing business and distribution services to facilitate company operations within Australia and New Zealand.
**Expertise & scope**
* Business and distribution services for market entry in Australia and New Zealand.
* Acts as a registered agent for key Australian regulatory bodies (AICIS, APVMA, TGA).
* Serves as a sponsor for Medsafe in New Zealand.
**Reputation / proof points**
* Registered agent for AICIS, APVMA, and TGA.
* Medsafe New Zealand sponsor.
Regulatory Services Australia (RSA) is a registered agent for AICIS, APVMA, and TGA in Australia, and a Medsafe New Zealand sponsor. They specialize in providing business and distribution services to facilitate company operations within Australia and New Zealand.
**Expertise & scope**
* Business and distribution services for market entry in Australia and New Zealand.
* Acts as a registered agent for key Australian regulatory bodies (AICIS, APVMA, TGA).
* Serves as a sponsor for Medsafe in New Zealand.
**Reputation / proof points**
* Registered agent for AICIS, APVMA, and TGA.
* Medsafe New Zealand sponsor.
Additional information
Regulatory Services Australia (RSA) provides essential business and distribution services to help companies navigate the regulatory landscape in Australia and New Zealand. Their expertise as a registered agent for AICIS, APVMA, and TGA, along with their role as a Medsafe New Zealand sponsor, positions them as a key partner for market access. Companies looking to establish or expand their presence in these regions can leverage RSA's services to ensure compliance and efficient operations. Their contact information, including postal and physical addresses in both Australia and New Zealand, is available for direct engagement.
Key Highlights
-
Registered agent for AICIS, APVMA, and TGA.
Source
“Regulatory Services Australia (RSA) is an AICIS, APVMA, and TGA registered agent”
-
Medsafe New Zealand sponsor.
Source
“and Medsafe New Zealand sponsor.”
-
Offers business and distribution services for Australia and New Zealand.
Source
“They offer business and distribution services to help companies operate in Australia and New Zealand.”
Certifications & Trust Signals
-
Registered agent for key Australian regulatory bodies.
Source
“Regulatory Services Australia (RSA) is an AICIS, APVMA, and TGA registered agent”
Buyer Snapshot
Best for
- Companies seeking to enter or operate in the Australian and New Zealand markets.
- Businesses requiring regulatory agent services for AICIS, APVMA, and TGA.
How engagement typically works
- Direct engagement for business and distribution services.
- Utilizing their registered agent and sponsor capabilities.
Typical deliverables
- Facilitation of business operations in Australia and New Zealand.
- Regulatory registration and sponsorship support.
Good to know
- Best when focused on market entry and ongoing operations in Australia and New Zealand.
HQ:
Sydney, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Digital health, SaMD, Medical devices
Portfolio:
1-5
Onboarding time:
3–30 days
Pricing model:
Custom pricing
Starting from:
AUD 2,500
Included services:
Annual ARTG charge reminders and continuity planning, TGA device classification and grouping, eBusiness Services account setup support, ARTG inclusion application preparation and submission
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Australian Entity State:
NSW
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Additional tga_sponsor_au Details
Supports Artg
true
Onboarding Steps
Contact via online message box to describe business and assistance needs.
