PharmOut
PharmOut is a Melbourne-headquartered GMP and regulatory consultancy serving pharmaceutical, medical device, and life-sciences manufacturers across Asia-Pacific through consulting, classroom and online training, and an annual industry forum.
- Company typePrivate
- Founded2006
- HeadquartersBurwood East, Australia
- Headcount101–250
- GTM typeB2B
- OfferingServices
What PharmOut does
PharmOut is a private Australian consulting firm founded in 2006 and headquartered in Melbourne (Burwood East), operating offices across Australia, China, Hong Kong, New Zealand, Singapore and the United Kingdom. The firm employs between 101 and 250 staff and self-positions as the largest medical device and pharmaceutical consultancy in the Asia Pacific region, serving regulated manufacturers and product distributors across pharmaceutical, medical device, medicinal cannabis, blood and tissue, complementary medicines, cosmetics, pesticides/veterinary, research laboratories and pharmacy segments.
The company's core product is a broad suite of GMP (Good Manufacturing Practice) and regulatory compliance services — auditing, regulatory affairs, pharmacovigilance, quality management system implementation, validation, engineering, technical writing, and interim/contract staffing — supported by architectural and engineering services for GMP-compliant facility design. Beyond consulting, PharmOut monetizes its compliance expertise through a multi-format training portfolio: public classroom courses in Australian cities, virtual instructor-led sessions via MS Teams and Zoom, and 65+ self-paced online courses on a dedicated eLearning platform (onlinegmptraining.com). It also runs the Pharma & Device Forum annual conference (running since 2011) and, in partnership with QikSolve, operates the FDA 483 Inspection Citation Tracking Tool that scrapes and visualizes FDA inspection data.
PharmOut's revenue model is professional-services fee-for-service, with consulting engagements priced per-hour or fixed-price and training priced per-seat (A$350–A$600+ GST per attendee). It also sells downloadable compliance templates as a one-time digital license, earns sponsorship and ticket revenue from its annual forum, and generates leads via content marketing (blog, whitepapers, free GMP tools, wiki). Customer acquisition is sales-led through direct enterprise engagement plus a self-serve eLearning channel reaching individual compliance buyers globally. The firm is a privately held, founder-led entity with no disclosed venture or private-equity investment and operates under ISO 9001:2015 and Climate Active Carbon Neutral certifications.
PharmOut firmographics
Firmographics- Name
- PharmOut
- Legal name
- PharmOut Pty Ltd
- Website
- https://pharmout.net
- Company type
- Private
- Founded year
- 2006
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- PharmOut is a Melbourne-headquartered GMP and regulatory consultancy serving pharmaceutical, medical device, and life-sciences manufacturers across Asia-Pacific through consulting, classroom and online training, and an annual industry forum.
- Ownership category
- akta.pro rank
PharmOut industry classification
Industry- Product category
- Pharmaceutical & Medical Device Regulatory Consulting
- NAICS
- Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds (524292)
- akta.pro primary industry
- Pharmacy Benefit Analytics, Reporting & Employer Consulting (HLAEAKAK)
Keywords
Where PharmOut is headquartered
LocationHeadquarters
- HQ city
- Burwood East
- HQ country
- Australia
- HQ region
- Oceania
Offices2 records
Markets served
PharmOut business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Consulting Services: Fee-for-service consulting engagements including auditing, GMP consulting, regulatory affairs, pharmacovigilance, validation, engineering, technical writing, and interim staff placement. Services offered on both fee for service and fixed price basis.
- Training Courses: Classroom training, virtual instructor-led training, and online GMP training courses (65+ courses). Public courses offered in small groups under 15 participants, plus onsite and custom group training.
- Downloadable Products: Templates for quality manuals, procedures, forms, and guides sold as downloadable digital products. Products are licensed for use at a single company.
- Annual Conferences: Pharma & Device Forum annual conferences on validation, GMP, and facility design, previously known as National Validation Forum and GMP Forum.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | PIC/S GMP Virtual Training |
| One time/ perpetual license | Pay-as-you-go | Classroom Training - Sydney |
| One time/ perpetual license | Pay-as-you-go | Classroom Training - Melbourne |
| One time/ perpetual license | Pay-as-you-go | Technical Writing Training - Virtual |
| One time/ perpetual license | Pay-as-you-go | Technical Writing Training - Classroom |
| One time/ perpetual license | Pay-as-you-go | Audit Preparation Workshop - Virtual |
| Subscription | Pay-as-you-go | Consulting Hours |
Go-to-market motion1 record
Distribution channels7 records
Marketing channels12 records
PharmOut product offering
Product offeringCore offering
PharmOut provides GMP, medical device, and regulatory consulting services to pharmaceutical and medical device manufacturers and product distributors in the Asia Pacific region. Its offerings include auditing, regulatory affairs, pharmacovigilance, validation engineering, facility design and architecture, project management, technical writing, and interim/contract staffing, complemented by instructor-led training, an online GMP e-learning platform, and an annual industry conference.
Product overview
PharmOut is a medical device and pharmaceutical GMP consulting firm offering a portfolio of consulting services, professional training products, and free industry tools. Its core offering is a broad suite of GMP consulting services (auditing, regulatory affairs, pharmacovigilance, architecture and engineering, validation, project management, and technical writing), supplemented by fee-for-service training programs delivered in-person and virtually (via MS Teams) and an online training portal (onlinegmptraining.com) with 65 courses. Annual conferences (Pharma & Device Forum™) and a free GMP tools library (checklists, whitepapers, wikis) serve as knowledge-sharing resources. The firm also co-developed an FDA 483 citation tracking tool with QikSolve.
Differentiator
Problem solved
Functional benefit
Products and services
- GMP Consulting Services A broad suite of Good Manufacturing Practice consulting services covering auditing, regulatory affairs, pharmacovigilance, project management, validation engineering, technical writing, and interim/contract staffing for pharmaceutical, medical device, and biopharmaceutical manufacturers.
- GMP Facility Design (Architecture & Engineering) Expert architectural and engineering services for the design of world-class health science facilities and highly regulated GMP-compliant manufacturing sites, ranging from initial feasibility through to detailed final design.
- GMP Training (Classroom & Virtual) Instructor-led GMP training courses covering PIC/S, EU GMP, FDA GMP, ISO 13485, ISO 14971, APVMA GMP, Computer Systems Validation (CSV), Quality Risk Management (ICH Q9), CAPA, Auditor Training, and Audit Preparation, delivered publicly in small groups under 15 attendees in Australian cities and virtually via MS Teams.
- Online GMP Training (onlinegmptraining.com) A dedicated eLearning platform offering 65 online GMP training courses covering data integrity, pharmacovigilance, qualification, validation, CFR 820, EU MDR for medical devices, and other pharma and medical device compliance topics. Courses provide 12 months of access.
- Pharma & Device Forum (Annual Conference) Annual industry conference organized by PharmOut since 2011 covering validation, GMP, and facility design topics. Originally the National Validation Forum (NVF), evolved into the GMP Forum and rebranded in 2024 to the Pharma-Device Forum for industry-specific programming.
- FDA 483 Inspection Citation Tracking Tool An interactive tracking and visualization tool for FDA inspection 483 citations, dynamically sourced from FDA databases. Allows filtering by Biologics, Devices, and Drugs; provides 10-year trend analysis, country-level drill-down, and CFR clause-level citation breakdown. Developed in partnership with QikSolve.
- Pharmacovigilance Consulting Services Comprehensive pharmacovigilance support including gap analysis, inspection/audit readiness assessments, and outsourced pharmacovigilance activities for sponsors, delivered by a team of experienced pharmacovigilance, regulatory, QA, and GMP professionals.
- Medicinal Cannabis Consulting End-to-end consulting for medicinal cannabis manufacturers covering facility design (propagation, vegetation, flowering, harvesting, extraction, filling, and storage stages), licensing support (TGA, ODC), and regulatory compliance in Australia.
- TGA Regulatory Affairs Consulting Regulatory affairs consulting for product registration in Australia and New Zealand, covering prescription medicines, biotech medicines, generic medicines, OTC medicines, medical devices, and literature-based submissions. Includes eCTD and NeeS dossier services.
- Technical Writing Training Course A 1-day intensive SOP writing and technical writing course for life sciences professionals, covering best-practice SOP structure, plain language documentation, GMP documentation compliance, and document usability testing. Available virtually via Zoom and in-person, with certification awarded on completion.
- Consultancy Hours (Downloadable Consulting Hours Pack) Templates for quality manuals, procedures, forms, and guides sold as downloadable digital products, plus block consulting hours available on a fee-for-service or fixed-price basis for validation and consulting engagements worldwide. Licensed for use at a single company.
Companies that use PharmOut
Customer profileSegments10 records
Ideal customer profiles3 records
PharmOut technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
PharmOut partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- StripeminorStripe is used as the secure payment gateway for processing credit card transactions on PharmOut's websites. Credit card details are passed through Stripe's secure server using encryption technology.
Scale indicators5 records
Recent moves7 records
Expansion highlights5 records
PharmOut competitors and assessment
Company assessmentDirect peers
- PharmaLex: Global pharmaceutical regulatory affairs and compliance consultancy (now part of Cencora). Closest functional peer to PharmOut, offering TGA-equivalent regional submissions, GMP consulting, pharmacovigilance, and quality systems work for pharma manufacturers.
- EduQuest: US-headquartered GMP, quality systems, and FDA regulatory consultancy run by former FDA investigators. Direct overlap with PharmOut's ex-regulator talent model and GMP/quality service portfolio.
- Kymanox: US-based GMP, regulatory, and engineering consultancy serving pharma, biologics, and medical device manufacturers. Comparable mid-sized niche player with similar consulting + technical writing + validation offering to PharmOut.
- Commissioning Agents Inc. US-based engineering and commissioning consultancy with strong GMP/CQV and validation practice for pharma manufacturers. Comparable technical engineering-led delivery model to PharmOut's facility design and validation services.
- NSF International (Health Sciences): NSF's Health Sciences division offers pharma consulting, training, and certification programs - directly comparable to PharmOut's training (65+ courses), conferences, and GMP consulting stack.
- The FDA Group: US consultancy focused on FDA regulatory, GMP auditing, and quality/compliance staffing for life sciences manufacturers. Same consulting-led, auditor-heavy model as PharmOut, with strong US FDA orientation that parallels PharmOut's TGA/PIC/S focus.
- Concordia Valsource: Specialised validation and GMP consulting firm serving pharma and medical device manufacturers. Comparable in size and scope to PharmOut's validation and computer systems validation (CSV) practice.
- PharmEng Technology: Canadian GMP consulting and pharmaceutical engineering firm offering validation, regulatory affairs, and facility design services to pharma manufacturers globally - directly mirrors PharmOut's core GMP + engineering + validation stack.
Broad incumbents
- Parexel International: Global CRO offering regulatory consulting, pharmacovigilance, and clinical services at much larger scale. Overlaps with PharmOut's regulatory affairs and pharmacovigilance work but as part of a far broader portfolio.
- IQVIA: World's largest CRO with regulatory and quality compliance consulting practices serving global pharma. Broad incumbent competing for the same enterprise clients as PharmOut on regulatory/GMP engagements.
Market position
Strengths1 record
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
PharmOut social profiles
Digital presencePharmOut compliance and trust
Trust signalCompliance2 records
PharmOut financial estimates
Financial estimateRevenue estimate
Valuation estimate
PharmOut leadership team
Management profileNumber of profiles
Profiles1 record
PharmOut funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PharmOut M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about PharmOut
What does PharmOut do?
PharmOut provides GMP, medical device, and regulatory consulting services to pharmaceutical and medical device manufacturers and product distributors in the Asia Pacific region. Its offerings include auditing, regulatory affairs, pharmacovigilance, validation engineering, facility design and architecture, project management, technical writing, and interim/contract staffing, complemented by instructor-led training, an online GMP e-learning platform, and an annual industry conference.
Is PharmOut a public or private company?
PharmOut is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was PharmOut founded?
PharmOut was founded in 2006. It employs 101 to 250 people.
Where is PharmOut based?
PharmOut is headquartered in Burwood East, Australia, in the Oceania region.
How does PharmOut make money?
Four revenue lines are on record. Consulting Services are the primary driver. The others are training Courses, downloadable Products and annual Conferences.
Who are PharmOut's main competitors?
Direct peers on record are PharmaLex, EduQuest, Kymanox, Commissioning Agents Inc., NSF International (Health Sciences), The FDA Group, Concordia Valsource and PharmEng Technology. Broad incumbents are Parexel International and IQVIA.
Does PharmOut have an API?
No public API is recorded for PharmOut.
What industry is PharmOut in?
PharmOut's product category is Pharmaceutical & Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAEAKAK, Pharmacy Benefit Analytics, Reporting & Employer Consulting. Its NAICS code is 524292.