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 offer expert guidance for TGA submissions, audits, and manufacturing licenses.
**Expertise & scope**
* Specializes in TGA regulatory affairs, including TGA GMP audit response support.
* Provides expert guidance for TGA approvals and ARTG registration.
* Offers consultancy services for pharmaceutical, veterinary, medical device, and IVD manufacturers.
* Assists with quality assurance, validation, and regulatory compliance to meet Australian and New Zealand standards.
* Can act as interim sponsors for companies entering the Australian market.
* Expertise covers facility designs, processing systems, cleanrooms, validation, and workflow designs.
* Services include GMP compliance, regulatory inspections, and post-audit remediation programs to TGA, FDA, and EMEA standards.
* Offers support for medicinal cannabis manufacturing licenses, including PIC/S Part I compliance and relevant Annexes.
**Reputation / proof points**
* Employs ex-Australian Therapeutic Goods Administration (TGA) inspectors as consultants.
* Recognized as a leading cannabis consulting firm.
PharmOut is an Australian consultancy firm with extensive experience in medical device and pharmaceutical regulatory affairs, GMP compliance, and quality systems. They offer expert guidance for TGA submissions, audits, and manufacturing licenses.
**Expertise & scope**
* Specializes in TGA regulatory affairs, including TGA GMP audit response support.
* Provides expert guidance for TGA approvals and ARTG registration.
* Offers consultancy services for pharmaceutical, veterinary, medical device, and IVD manufacturers.
* Assists with quality assurance, validation, and regulatory compliance to meet Australian and New Zealand standards.
* Can act as interim sponsors for companies entering the Australian market.
* Expertise covers facility designs, processing systems, cleanrooms, validation, and workflow designs.
* Services include GMP compliance, regulatory inspections, and post-audit remediation programs to TGA, FDA, and EMEA standards.
* Offers support for medicinal cannabis manufacturing licenses, including PIC/S Part I compliance and relevant Annexes.
**Reputation / proof points**
* Employs ex-Australian Therapeutic Goods Administration (TGA) inspectors as consultants.
* Recognized as a leading cannabis consulting firm.
Additional information
PharmOut's services are tailored to help clients navigate the complex regulatory landscape for therapeutic goods in Australia. They emphasize 'designing-in' quality from the initial planning stages through to facility design and manufacturing processes. Their team includes architects, engineers, validation experts, and GMP trainers, many of whom have prior experience with regulatory bodies like the TGA. This deep understanding allows them to provide comprehensive support for TGA submissions, GMP compliance, and audit responses, ensuring products meet stringent regulatory standards before entering the Australian Register of Therapeutic Goods (ARTG).
Key Highlights
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Employs ex-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 TGA approvals and ARTG registration.
Source
“Products must be registered by the TGA if they are: TGA approval and ARTG | TGA GMP Audit Responses”
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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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Specializes in GMP facility design and validation.
Source
“GMP facility design for manufacturing sites and scientific laboratories requires very specific knowledge and experience.”
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Assists with medicinal cannabis manufacturing licenses.
Source
“Two manufacturing licences are required for the manufacture of medicinal cannabis FDF – one from the Australian Office of Drug Control (ODC) and another from the Australian TGA.”
Certifications & Trust Signals
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Recognized as a leading cannabis consulting firm.
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 requiring GMP compliance and facility design support.
- Businesses needing interim sponsorship in Australia.
- Firms navigating medicinal cannabis licensing.
How engagement typically works
- Fee-for-service or fixed-price projects.
- Collaborative support throughout the regulatory process.
- Expert consultation and hands-on assistance.
Typical deliverables
- TGA submission support.
- ARTG registration guidance.
- GMP audit responses and remediation plans.
- Facility design and validation documentation.
- Interim sponsorship services.
- Medicinal cannabis manufacturing license applications.
Good to know
- Best when engaging early in the product development or facility design lifecycle.
- 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
Can act as interim sponsors to obtain a TGA manufacturing certificate before listing or registering a drug or device on the ARTG.
