PharmOut
★★★★★
4.8
/ 5
•
86 reviews
PharmOut is a leading Australian consultancy firm specializing in medical device and pharmaceutical regulatory affairs, GMP compliance, and quality systems. They offer expert guidance for TGA submissions, audits, and manufacturing licenses.
Established in 2006, PharmOut has grown to become the region's largest medical device and pharmaceutical consultancy firm, headquartered in Melbourne, Australia. They provide a comprehensive range of services including GMP, medical device, and regulatory consulting to manufacturers and product distributors across the Asia Pacific region. PharmOut's expertise extends to assisting clients with TGA regulatory affairs, including TGA GMP audit response, ARTG registration, and obtaining manufacturing licenses for products like medicinal cannabis. They also offer support for APVMA GMP compliance for veterinary medicines and agricultural chemical products. Their team comprises experienced consultants, including former TGA inspectors, who help clients navigate complex regulatory landscapes, implement quality management systems (QMS), and achieve compliance with international standards such as ISO 13485, EU GMP, and US FDA GMP. PharmOut also provides services in facility design, validation, and contracting of QA and GMP professionals.
About
**Who they are**
PharmOut is an Australian consultancy firm with extensive experience in medical device and pharmaceutical regulatory affairs, GMP compliance, and quality systems. They provide expert guidance for TGA submissions, audits, and manufacturing licenses.
**Expertise & scope**
* Specializes in TGA regulatory affairs, including TGA GMP audit response and ARTG registration.
* Offers support for product approval and registration in the Australian Register of Therapeutic Goods (ARTG).
* Provides services for pharmaceutical, veterinary, medical device, and IVD manufacturers.
* Assists with facility design, engineering, validation, and quality management systems (QMS) to meet TGA and international GMP standards.
* Expertise includes medicinal cannabis manufacturing licenses, requiring compliance with PIC/S Guide to GMP.
* Consultants include former Australian TGA inspectors.
**Reputation / proof points**
* Recognized as a leading cannabis consulting firm.
* Works with TGA, FDA, and EMEA standards for auditing and compliance.
PharmOut is an Australian consultancy firm with extensive experience in medical device and pharmaceutical regulatory affairs, GMP compliance, and quality systems. They provide expert guidance for TGA submissions, audits, and manufacturing licenses.
**Expertise & scope**
* Specializes in TGA regulatory affairs, including TGA GMP audit response and ARTG registration.
* Offers support for product approval and registration in the Australian Register of Therapeutic Goods (ARTG).
* Provides services for pharmaceutical, veterinary, medical device, and IVD manufacturers.
* Assists with facility design, engineering, validation, and quality management systems (QMS) to meet TGA and international GMP standards.
* Expertise includes medicinal cannabis manufacturing licenses, requiring compliance with PIC/S Guide to GMP.
* Consultants include former Australian TGA inspectors.
**Reputation / proof points**
* Recognized as a leading cannabis consulting firm.
* Works with TGA, FDA, and EMEA standards for auditing and compliance.
Additional information
PharmOut can act as interim sponsors for companies entering the Australian market for the first time, enabling them to obtain a TGA manufacturing certificate before listing or registering their drug or device on the ARTG. They also offer GMP training and can assist with developing compliance roadmaps to navigate complex regulations. Their services cater to various stages of a product lifecycle, from initial site selection and facility design to ongoing quality management and audit response.
Key Highlights
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Specializes in Australian TGA regulatory affairs and GMP compliance.
Source
“PharmOut’s TGA and Regulatory Affairs consultancy services / TGA GMP Audit Responses support”
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Employs former Australian TGA inspectors as consultants.
Source
“PharmOut employs a number of ex-Australian Therapeutic Goods Administration (TGA) inspectors as TGA consultants”
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Provides support for ARTG registration for drugs and medical devices.
Source
“Products must be registered by the TGA if they are: ... Products falling into the therapeutic goods category must be approved and registered by the TGA in the Australian Register of Therapeutic Goods (ARTG)”
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Offers interim sponsorship services for market entry.
Source
“If you are entering the Australian market for the first time, and have not yet found a Distributor, we can act as interim sponsors”
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Expertise in GMP facility design and validation for pharmaceutical and medical device industries.
Source
“GMP facility design for manufacturing sites and scientific laboratories requires very specific knowledge and experience.”
Certifications & Trust Signals
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Consultancy covers TGA, FDA, and EMEA standards.
Source
“Our auditing options cover GMP Compliance, Regulatory Inspections and Post-Audit Remediation Programs – all to TGA, FDA and EMEA standards.”
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Recognized as a leading firm in cannabis consulting.
Source
“More recently PharmOut has been recognised as one of the world’s leading cannabis consulting firms.”
Buyer Snapshot
Best for
- Companies seeking TGA approval and ARTG registration.
- Manufacturers needing GMP compliance and facility design.
- Firms requiring regulatory affairs support in Australia and New Zealand.
How engagement typically works
- Fee-for-service or fixed-price projects.
- Consultancy and interim staffing.
- Project-based support for specific regulatory needs.
Typical deliverables
- TGA submission and registration support.
- GMP audit response and remediation plans.
- Facility design and validation documentation.
- Quality management system development.
- Interim sponsorship services.
Good to know
- Best when engaging early in the product development or facility design process.
- Requires clear definition of project scope for fixed-price engagements.
HQ:
Melbourne, AU
Languages:
English
Timezones:
Australia/Sydney
Claim status:
Listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Hospital equipment, Consumables, Medical devices
Portfolio:
26-100
Onboarding time:
5–30 days
Pricing model:
Per project
Starting from:
AUD 6,500
Included services:
Sponsor address and labeling review, Annual ARTG charge reminders and continuity planning, eBusiness Services account setup support, Post-market vigilance support and incident reporting workflow
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:
Melbourne, Australia
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Additional tga_sponsor_au Details
Device Classes Supported
Class I-III
Supports Artg
Yes
Onboarding Steps
The process involves site selection, facility designs, processing systems, cleanrooms, validation, workflow designs, packaging and distribution compliance, and employee GMP training. For medicinal cannabis FDF, TGA licensing requires meeting PIC/S Part I compliance and relevant Annexes, alongside product standards like TGO 77 and TGO 93.
Recall Vigilance Support
No
