Accelagen
Accelagen is a Melbourne-headquartered CRO providing clinical development and regulatory affairs services—including local Australian sponsor and Marketing Authorisation Holder representation—to biotechs, multinational pharma, medical-device developers, and international firms seeking Australian market entry.
- Company typePrivate
- Founded2010
- HeadquartersHawthorn, Australia
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Accelagen does
Accelagen is an Australian-headquartered Contract Research Organisation (CRO) founded in 2010 by Greg Plunkett, providing integrated clinical development and regulatory affairs services to pharmaceutical and medical-device developers. The company delivers full-lifecycle clinical trial management (Phase I through Phase IV) and end-to-end regulatory services—including local sponsor and Marketing Authorisation Holder (MAH) representation in Australia—targeting small-to-mid biotechs, multinational pharmaceutical companies, and international firms seeking Australian market entry. Named customers include QBiotics, Kiora Pharmaceuticals, Alphyn Biologics, Bionics Institute, Griffith University, and MSN Group, with case studies spanning First-in-Human studies, device approvals, and orphan drug submissions.
Accelagen reports delivery of 100+ clinical trials, 339 device approvals, 57 IND/IDE submissions, 132 trial sites managed, and 50+ marketing applications across jurisdictions including Australia, New Zealand, the US, Europe, and Asia-Pacific. The technology stack is conventional CRO infrastructure: CDISC-compliant EDC and clinical data management systems, biostatistics and statistical programming, pharmacovigilance workflows, and multi-jurisdiction submission publishing for TGA, FDA, and EMA. The firm differentiates via a "reverse journey mapping" methodology—an end-state-first planning framework intended to reduce re-submissions and accelerate approvals.
The business operates on project-based, multi-year professional services contracts scoped via RFP, with no public pricing or rate cards. Go-to-market is sales-led, relying on direct CEO/CGO engagement, industry conferences (notably AusBiotech), content marketing (Insights blog, Bench 2 Breakthrough podcast), and RFP submission. The company remains founder- and management-owned, with no disclosed external institutional funding, and operates with 11-50 staff (approximately 40% remote/interstate) from headquarters in Hawthorn East, Victoria.
Accelagen firmographics
Firmographics- Name
- Accelagen
- Legal name
- Accelagen Pty Ltd
- Website
- https://accelagen.com.au
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Accelagen is a Melbourne-headquartered CRO providing clinical development and regulatory affairs services—including local Australian sponsor and Marketing Authorisation Holder representation—to biotechs, multinational pharma, medical-device developers, and international firms seeking Australian market entry.
- Ownership category
- akta.pro rank
Accelagen industry classification
Industry- Product category
- Contract Research Organisation (CRO) Services
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industries
- Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)
Keywords
Where Accelagen is headquartered
LocationHeadquarters
- HQ city
- Hawthorn
- HQ country
- Australia
- HQ region
- Oceania
Offices1 record
Markets served
Accelagen business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure, Others
Revenue model
- Clinical Development Services: Project-based fees for clinical trial management including clinical project management, site identification and management, patient recruitment, medical and safety management, biostatistics and data management, medical writing, pharmacokinetics, and HREC submissions.
- Regulatory Affairs Services: Fees for regulatory strategy, marketing authorisation holder services, dossier development and gap analysis, submission publishing and management, product lifecycle management, and safety and pharmacovigilance services.
- Local Sponsor Services: Acting as local Australian sponsor and Marketing Authorisation Holder (MAH) for international companies seeking regulatory approval in Australia, with over 50 successful marketing applications completed.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels6 records
Accelagen product offering
Product offeringCore offering
Accelagen is a contract research organisation (CRO) that provides clinical development and regulatory affairs services to biotech and pharmaceutical companies. It manages end-to-end clinical trials from First-in-Human studies through Phase IV, including project management, site identification, patient recruitment, medical and safety monitoring, biostatistics, data management, medical writing, and pharmacokinetics. It also delivers regulatory strategy, marketing authorisation holder services, dossier development, submission publishing, product lifecycle management, and pharmacovigilance across Australia, New Zealand, North America, and Europe.
Product overview
Accelagen is a global Contract Research Organisation (CRO) offering integrated clinical development and regulatory affairs services. The company's core offering comprises 15 distinct service modules organized into two main divisions: Clinical Development (covering project management, ethics submissions, site management, patient recruitment, medical/safety monitoring, biostatistics, data management, medical writing, and pharmacokinetics) and Regulatory Affairs (covering regulatory strategy, marketing authorisation holder services, dossier development, submission management, lifecycle management, and pharmacovigilance). Services span from First in Human studies through Phase IV and market authorization across Asia-Pacific, North America, and Europe. The company also produces educational content through its Bench 2 Breakthrough podcast series.
Differentiator
Problem solved
Functional benefit
Products and services
- Clinical Development Services End-to-end clinical trial management service covering project management, ethics submissions, site identification and management, patient recruitment, medical and safety monitoring, biostatistics, data management, medical writing, and pharmacokinetics from First-in-Human through Phase IV studies. Designed for biotech and pharmaceutical companies lacking in-house clinical operations infrastructure.
- Regulatory Affairs Services Comprehensive regulatory strategy and market authorisation services including regulatory pathway development, dossier development and gap analysis, submission publishing and management, product lifecycle management, and safety and pharmacovigilance. Spans TGA, FDA, EMA and other international regulatory authorities.
- Marketing Authorisation Holder / Local Sponsor Services Acting as local Australian sponsor and Marketing Authorisation Holder (MAH) for international companies seeking regulatory approval in Australia. Enables overseas pharmaceutical and biotech companies to enter the Australian market without establishing a local entity, with over 50 successful marketing applications completed to date.
Quantifiable outcome
- 339 Device Approvals achieved
- +5 more outcomes
Companies that use Accelagen
Customer profileNamed customers6 records
Segments4 records
Ideal customer profiles4 records
Accelagen technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Accelagen partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- AusBiotechcoreActive participation in AusBiotech International Conference 2025 with record attendance. CEO Greg Plunkett participated in panel sessions on cell and gene therapy ecosystem. Accelagen serves as an integral part of Australia's biotech ecosystem supporting sector growth through collaboration with government and industry stakeholders.
Scale indicators12 records
Recent moves8 records
Expansion highlights5 records
Accelagen competitors and assessment
Company assessmentDirect peers
- Novotech: Asia-Pacific-focused CRO headquartered in Australia, providing clinical trial and regulatory services to biotech clients. Directly comparable given similar regional focus, biotech client base, and integrated clinical/regulatory service model.
- George Clinical: Australia-headquartered CRO with global operations, offering full-service clinical trial management across Asia-Pacific, North America and Europe. Comparable in regional focus, biotech clientele, and trial execution capabilities.
Broad incumbents
- Charles River Laboratories: Global CRO offering preclinical and clinical services, including biostatistics, data management, and regulatory support. Comparable in the data management and biostatistics/CDISC-aligned services Accelagen provides.
- Parexel: Major global CRO offering clinical operations, regulatory affairs, and pharmacovigilance services. Overlapping service mix with Accelagen, particularly in regulatory strategy and clinical trial management.
- ICON plc: Global CRO providing clinical research, regulatory consulting and bioanalytical services across all phases. Comparable service portfolio, though at much larger scale and broader geographic footprint.
- IQVIA: Largest global CRO and life sciences services firm offering integrated clinical, regulatory, and real-world evidence services. Overlaps with Accelagen across clinical trial management and regulatory submissions but operates at vastly larger scale.
- Syneos Health: Global biopharmaceutical solutions organization offering clinical development and commercialization services. Comparable in providing end-to-end clinical and regulatory services to biotech and pharma sponsors.
Regional players
- Australian Clinical Labs / Clinical Trial Services (e.g., CMAX Clinical Research): Australia-based clinical trial site and CRO services organization. Comparable as a regional Australian CRO serving biotech and pharma sponsors with early-phase trial capabilities.
- Linear Clinical Research: Australia-based early-phase clinical trial specialist with embedded Phase 1 unit. Comparable as an Australian CRO serving biotech and pharma with clinical trial execution capabilities.
Emerging players
- Clinipace Worldwide: Mid-size global CRO with therapeutic-area focus and digital clinical trial platform. Comparable in serving small-to-mid biotechs with full-service clinical and regulatory offerings.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
Accelagen social profiles
Digital presenceAccelagen compliance and trust
Trust signalCompliance1 record
Accelagen financial estimates
Financial estimateRevenue estimate
Valuation estimate
Accelagen leadership team
Management profileNumber of profiles
Profiles12 records
Accelagen funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Accelagen 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 Accelagen
What does Accelagen do?
Accelagen is a contract research organisation (CRO) that provides clinical development and regulatory affairs services to biotech and pharmaceutical companies. It manages end-to-end clinical trials from First-in-Human studies through Phase IV, including project management, site identification, patient recruitment, medical and safety monitoring, biostatistics, data management, medical writing, and pharmacokinetics. It also delivers regulatory strategy, marketing authorisation holder services, dossier development, submission publishing, product lifecycle management, and pharmacovigilance across Australia, New Zealand, North America, and Europe.
Is Accelagen a public or private company?
Accelagen is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Accelagen founded?
Accelagen was founded in 2010. It employs 51 to 100 people.
Where is Accelagen based?
Accelagen is headquartered in Hawthorn, Australia, in the Oceania region.
How does Accelagen make money?
Three revenue lines are on record. Clinical Development Services are the primary driver. The others are regulatory Affairs Services and local Sponsor Services.
Who are Accelagen's main competitors?
Direct peers on record are Novotech and George Clinical. Broad incumbents are Charles River Laboratories, Parexel, ICON plc, IQVIA and Syneos Health. Regional players are Australian Clinical Labs / Clinical Trial Services (e.g., CMAX Clinical Research) and Linear Clinical Research. Clinipace Worldwide is listed as an emerging player.
Does Accelagen have an API?
No public API is recorded for Accelagen.
What industry is Accelagen in?
Accelagen's product category is Contract Research Organisation (CRO) Services. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs. Its NAICS code is 5417 and its SIC code is 8731.