Adjutor (Regulatory Consulting Australia)
Adjutor Healthcare Pty Ltd
Adjutor provides expert regulatory consulting and commercialisation services for medicines and medical devices in Australia and globally. They specialize in navigating pathways like TGA provisional registration and the ACCESS Consortium.
The Adjutor Group, including Adjutor Healthcare Pty Ltd, offers comprehensive regulatory consulting and commercialisation services for medicines and medical devices. They are experts in guiding clients through complex regulatory landscapes, including Australia's TGA provisional registration pathway and international initiatives like the ACCESS Consortium. Their services span product development, regulatory affairs, market access, quality management, and clinical trial support. With a focus on accelerating patient access to new therapies, Adjutor provides tailored teams to support businesses at any stage of product development or lifecycle. They are adept at designing strategies for efficient market entry and ensuring effective commercialisation. Their global network allows for seamless international service delivery, helping clients meet their goals across various markets. Adjutor emphasizes a collaborative and responsive approach, working closely with clients to achieve successful outcomes. They are committed to providing high-quality, timely, and effective solutions, positioning themselves as a key partner for biopharmaceutical companies seeking to navigate global regulatory challenges and expand market reach.
About
**Who they are**
Adjutor (Regulatory Consulting Australia) is a consulting firm specializing in regulatory affairs and market access for medicines and medical devices. They operate globally, with a strong focus on the Australian market.
**Expertise & scope**
* Navigating the TGA provisional registration pathway for prescription medicines in Australia, which allows earlier patient access based on preliminary clinical data.
* Facilitating medicine approvals through international work-sharing initiatives like the ACCESS Consortium, involving Australia, Canada, Singapore, Switzerland, and the UK.
* Providing regulatory consulting and commercialisation services for both the Australian and international markets.
* Expertise in drug and device development, regulatory affairs, market access, quality, training, and sponsorship.
**Reputation / proof points**
* Partnered with clients to achieve successes in Australia, Singapore, and South Korea.
* Contributes to accelerating patient access to new therapies through various regulatory pathways.
Adjutor (Regulatory Consulting Australia) is a consulting firm specializing in regulatory affairs and market access for medicines and medical devices. They operate globally, with a strong focus on the Australian market.
**Expertise & scope**
* Navigating the TGA provisional registration pathway for prescription medicines in Australia, which allows earlier patient access based on preliminary clinical data.
* Facilitating medicine approvals through international work-sharing initiatives like the ACCESS Consortium, involving Australia, Canada, Singapore, Switzerland, and the UK.
* Providing regulatory consulting and commercialisation services for both the Australian and international markets.
* Expertise in drug and device development, regulatory affairs, market access, quality, training, and sponsorship.
**Reputation / proof points**
* Partnered with clients to achieve successes in Australia, Singapore, and South Korea.
* Contributes to accelerating patient access to new therapies through various regulatory pathways.
Additional information
Adjutor emphasizes a collaborative approach, working as a unified team with clients to achieve their goals. They offer services across the entire product lifecycle, from development through to commercialisation. For specific product inquiries, they provide dedicated contact points. Their services are structured under Adjutor Healthcare and Adjutor Clinical, covering strategy, project management, regulatory affairs, clinical trial services, and more. They highlight their ability to provide seamless services across international markets, leveraging a worldwide network.
Key Highlights
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Specializes in the TGA provisional registration pathway for medicines in Australia.
Source
“In Australia, the Therapeutic Goods Administration (TGA) offers a provisional registration pathway for prescription medicines.”
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Facilitates medicine approvals through the ACCESS Consortium, a collaboration of regulatory authorities.
Source
“The Access Consortium is a coalition of like-minded regulatory authorities working together to promote greater regulatory collaboration”
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Provides comprehensive services including regulatory affairs, market access, and commercialization.
Source
“Our ServicesAdjutor HealthcareStrategy and Project ManagementDrug and Device DevelopmentRegulatory Affairs and Market AccessQuality and TrainingSponsorship and Commercialisation”
Certifications & Trust Signals
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Operates with a worldwide network for international product commercialization.
Source
“The Adjutor Group includes a worldwide network that spans right across the globe.”
Buyer Snapshot
Best for
- Companies seeking TGA registration and market access in Australia.
- Pharmaceutical and biotechnology firms aiming for early market entry.
- Businesses needing support with international regulatory collaboration.
How engagement typically works
- Collaborative and collegial approach.
- Confidential project discussions.
- Seamless international service delivery.
Typical deliverables
- TGA provisional registration guidance.
- ACCESS Consortium application support.
- Regulatory affairs strategy.
- Market access planning.
- Commercialization support.
Good to know
- Best when engaging for complex regulatory pathways in Australia and globally.
- Requires clear project needs for confidential discussion.
HQ:
Melbourne, 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:
3–14 days
Pricing model:
Per project
Starting from:
AUD 4,800
Included services:
Change notification and variation assessment, Sponsor address and labeling review, Annual ARTG charge reminders and continuity planning, eBusiness Services account setup support
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:
Pty Ltd
Recall Vigilance Support:
No
Fsca Recall Support:
No
Additional tga_sponsor_au Details
Supports Artg
true
Onboarding Steps
Contact for a confidential discussion of project needs and services; complete a contact form for response.
