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 support.
* Assists with TGA approval and ARTG (Australian Register of Therapeutic Goods) registration for products intended for the Australian market.
* Offers services for various therapeutic goods, including prescription medicines, biotech medicines, generic medicines, OTC medicines, and medical devices (Class I-III).
* Provides support for facility and process designs, cleanrooms, validation, workflow designs, and packaging/distribution (GMP/GDP and GxP requirements).
* Consultants include ex-Australian TGA inspectors, offering expertise in GMP and regulatory requirements for pharmaceutical, veterinary, medical device, and IVD manufacturers.
* Can act as interim sponsors for companies entering the Australian market for the first time.
* Offers architectural, engineering, QA, and validation services to medicinal cannabis, medical device, pharmaceutical, and veterinary manufacturing industries.
* Provides GMP compliance auditing and remediation services, including support for Electronic Records and Electronic Signatures (ERES) compliance (21 CFR Part 11 / Annex 11).
* Expertise extends to international regulatory standards such as FDA and EMEA.
* Specializes in TGA medicinal cannabis manufacturing licenses for final dosage forms, ensuring compliance with PIC/S Guide to GMP.
**Reputation / proof points**
* Recognized as one of the world’s leading cannabis consulting firms.
* Consultants have previously held roles within regulatory bodies such as the Australian Therapeutic Goods Administration (TGA).
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 support.
* Assists with TGA approval and ARTG (Australian Register of Therapeutic Goods) registration for products intended for the Australian market.
* Offers services for various therapeutic goods, including prescription medicines, biotech medicines, generic medicines, OTC medicines, and medical devices (Class I-III).
* Provides support for facility and process designs, cleanrooms, validation, workflow designs, and packaging/distribution (GMP/GDP and GxP requirements).
* Consultants include ex-Australian TGA inspectors, offering expertise in GMP and regulatory requirements for pharmaceutical, veterinary, medical device, and IVD manufacturers.
* Can act as interim sponsors for companies entering the Australian market for the first time.
* Offers architectural, engineering, QA, and validation services to medicinal cannabis, medical device, pharmaceutical, and veterinary manufacturing industries.
* Provides GMP compliance auditing and remediation services, including support for Electronic Records and Electronic Signatures (ERES) compliance (21 CFR Part 11 / Annex 11).
* Expertise extends to international regulatory standards such as FDA and EMEA.
* Specializes in TGA medicinal cannabis manufacturing licenses for final dosage forms, ensuring compliance with PIC/S Guide to GMP.
**Reputation / proof points**
* Recognized as one of the world’s leading cannabis consulting firms.
* Consultants have previously held roles within regulatory bodies such as the Australian Therapeutic Goods Administration (TGA).
Additional information
PharmOut's services are designed to navigate the complexities of the Australian regulatory landscape, particularly concerning the Therapeutic Goods Administration (TGA). They emphasize a 'design-in' quality approach, ensuring regulatory requirements are integrated from the initial planning stages through to facility design and manufacturing processes. For companies new to the Australian market, PharmOut can serve as an interim sponsor, facilitating the acquisition of a TGA manufacturing certificate before listing products on the ARTG. Their team comprises former TGA inspectors, providing a unique perspective on compliance and audit readiness. Engagement can be on a fee-for-service or fixed-price basis, offering flexibility for clients' project needs.
Key Highlights
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Specializes in TGA regulatory affairs and GMP compliance for medical devices and pharmaceuticals in Australia.
Source
“PharmOut’s TGA and Regulatory Affairs consultancy services / TGA GMP Audit Responses support”
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Employs ex-Australian TGA inspectors as consultants for expert advice.
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 and can act as interim sponsors 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 comprehensive services including facility design, validation, and quality system development.
Source
“PharmOut’s pharmaceutical architects have extensive experience in designing a wide variety of pharmaceutical, medical device and complementary medicine manufacturing and distribution facilities.”
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Expertise in medicinal cannabis licensing and compliance with PIC/S GMP standards.
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 expertise.
- Businesses needing support with regulatory affairs and quality systems in Australia.
How engagement typically works
- Fee-for-service basis.
- Fixed price basis.
- Acting as interim sponsors.
Typical deliverables
- TGA submission support.
- GMP audit response and remediation.
- Facility and process design.
- ARTG registration assistance.
- Quality Management System (QMS) development.
- Interim sponsorship.
Good to know
- Best when engaging early in the product development or facility design lifecycle.
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.
