PharmOut
★★★★★
4.9
/ 5
•
83 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 specializing in regulatory affairs, GMP compliance, and quality systems for the medical device and pharmaceutical industries. They leverage expertise from former Australian Therapeutic Goods Administration (TGA) inspectors.
**Expertise & scope**
* Guidance for TGA submissions, ARTG registration, and manufacturing licenses.
* Support for product classification and regulatory frameworks within Australia.
* Assistance with GMP audit responses and remediation efforts.
* Expertise in facility and process designs, including cleanrooms and validation.
* Consulting on medicinal cannabis manufacturing licenses, including PIC/S GMP compliance.
* Services cover a range of therapeutic goods, including prescription medicines, biotech medicines, generic medicines, OTC medicines, and medical devices (Class I-III).
* Support for quality management systems (QMS), CAPA, and technical writing.
* International GMP compliance audits to TGA, FDA, and EMEA standards.
**Reputation / proof points**
* Employs ex-Australian TGA inspectors.
* Proven track record in delivering successful projects for medicinal cannabis, medical device, pharmaceutical, and veterinary industries.
PharmOut is an Australian consultancy firm specializing in regulatory affairs, GMP compliance, and quality systems for the medical device and pharmaceutical industries. They leverage expertise from former Australian Therapeutic Goods Administration (TGA) inspectors.
**Expertise & scope**
* Guidance for TGA submissions, ARTG registration, and manufacturing licenses.
* Support for product classification and regulatory frameworks within Australia.
* Assistance with GMP audit responses and remediation efforts.
* Expertise in facility and process designs, including cleanrooms and validation.
* Consulting on medicinal cannabis manufacturing licenses, including PIC/S GMP compliance.
* Services cover a range of therapeutic goods, including prescription medicines, biotech medicines, generic medicines, OTC medicines, and medical devices (Class I-III).
* Support for quality management systems (QMS), CAPA, and technical writing.
* International GMP compliance audits to TGA, FDA, and EMEA standards.
**Reputation / proof points**
* Employs ex-Australian TGA inspectors.
* Proven track record in delivering successful projects for medicinal cannabis, medical device, pharmaceutical, and veterinary industries.
Additional information
PharmOut provides comprehensive support for companies navigating the Australian regulatory landscape, particularly concerning the TGA. Their services extend from initial market entry strategy and ARTG registration to ongoing GMP compliance and audit readiness. They can act as interim sponsors for companies new to the Australian market, facilitating TGA manufacturing certificates before ARTG listing. Their team's background, including former TGA inspectors, offers practical insights into regulatory expectations. PharmOut also assists with facility design and validation, ensuring that quality is built into manufacturing processes from the ground up, aligning with standards such as PIC/S GMP.
Key Highlights
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PharmOut 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 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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Offers support for TGA approval and ARTG registration.
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”
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Specializes 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.”
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Consults on medicinal cannabis manufacturing licenses, including PIC/S GMP compliance.
Source
“The PIC/S Guide to GMP is the essential standard for those intending to manufacture medicines for supply within Australia.”
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.
- Businesses needing support with regulatory affairs and quality systems.
How engagement typically works
- Fee-for-service or fixed-price projects.
- Interim sponsorship.
- Consulting and expert guidance.
Typical deliverables
- TGA submission support
- ARTG registration assistance
- GMP audit response strategies
- Facility design and validation plans
- Quality management system development
- Interim sponsorship services
Good to know
- Best when requiring specialized knowledge of Australian TGA regulations and GMP standards.
HQ:
Melbourne, AU
Languages:
English
Timezones:
Australia/Sydney
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.
