Pharmaceutical CDMO
in Melbourne, Australia
Bringing better treatments and global impact to life – one clinical trial product at a time.
Realise your vision. Partner with PharmSky.
Full CMC Services, Formulation & Product Development, Generics, Analytical Testing, Clinical Trial Manufacture, Nano Liquid Emulsions, Injectables, Topicals, Oral Liquids & Solid Orals.
Australian Advantage
PharmSky allows clients to get their product into the clinic faster, and save significant costs along the way.
SPEED
Clinical Trial start-up timelines around 6-8 weeks from ethics committee to approval
COST
Generous Tax Scheme, Potential 43.5 % R&D Cash Refund on all our services
EFFICIENCY
No CTA or IND required just ethics approval and notification to the TGA
QUALITY
Clinical Data in Australia is accepted by FDA (US) and EMA (EU)
R&D TAX INCENTIVES
All our services, including formulation development and manufacturing, may be eligible for a 43.5% R&D Tax Incentive cash refund.
Our Services
Formulation Development
Formulation development is essential for optimising drug performance, ensuring patient safety and compliance, and meeting regulatory requirements in the pharmaceutical industry.It is a critical aspect of the drug…
Analytical Services
PharmSky Research provide analytical support throughout the entire life cycle of a product starting from early phase drug development through GMP manufacture, regulatory submission, and post…
Clinical Trial Manufacturing
PharmSky’s pilot scale manufacturing facility can safely and rapidly manufacture clinical material suitable for early-stage clinical trials. Following the FDA’s cGMP guidance for Phase I Investigational Drugs…
Nanotechnology Platform
The use of nanotechnology in pharmaceutical products has become more important as selective drug delivery and the use of compounds with limited solubility becomes more prominent. Nanoscale drug delivery system…
GMP Storage
GMP storage and handling play a crucial role in maintaining the integrity of products and ensuring regulatory compliance. It is critical for pharmaceuticals, food and cosmetics, where compliance with…
Complex Generic Development
With decades of experience in simple and complex generic product development, PharmSky’s scientists are well versed to assist in the development of your generic, value-added and differentiated generics.
Regulatory Compliance
A well designed and stage appropriate quality management system (QMS) is essential for development and commercialization. We understand the complexities of managing quality and regulatory compliance…
ICH Stability
PharmSky can perform stability studies according to ICH guidelines to monitor the physical, chemical, biological, and microbiological attributes of products stored under accelerated and real time conditions over a defined period.
Specialised Analytical Services
Throughout its journey from production using starting materials to storage and eventual administration to the patient, a drug product will contact manufacturing components, packaging systems or delivery devices…
Controlled Substances
Contact Us Today
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Over 25 years experience in drug product development, complex formulation, injectables, regulatory and intellectual property space.
PharmSky is a Melbourne-based Contract Development and Manufacturing Organisation (CDMO) committed to bringing better treatments and global impact to life — one clinical trial product at a time. We provide end-to-end support from laboratory-based research and analytical development through to formulation, process optimisation, and GMP manufacturing.
Established to give innovators worldwide a launchpad to turn their ideas into registered, market-ready products, PharmSky offers integrated services under one roof.
Our leadership team brings over 25 years of experience each across drug development, complex formulations, injectables, regulatory affairs, and intellectual property — ensuring expert execution at every stage.
Recent Articles and News
A pharmaceutical drug development company built for early-stage innovators
PharmSky supports biotech, pharmaceutical and life sciences teams that need practical, science-led development support without unnecessary complexity. As a Melbourne-based pharmaceutical research and development company, we help bridge the gap between promising therapeutic ideas and clinical-ready products.
Our integrated model brings pharmaceutical research services, formulation development, analytical testing, process optimisation and clinical trial manufacturing together under one roof. This gives sponsors a clearer, more efficient path from laboratory concept to GMP-manufactured clinical material, supported by experienced scientists who understand the technical, regulatory and commercial pressures of drug development.
For local and international companies seeking a pharmaceutical CDMO in Australia, PharmSky offers the depth of a specialist pharmaceutical services company with the agility needed for early-phase programs. Our team works across complex formulations, injectables, nano liquid emulsions, oral liquids, solid oral dosage forms, topicals, controlled substances and differentiated generic products.
We’re well positioned to support biotech research in Melbourne and global development programs looking to access Australia’s respected clinical trial environment. From first feasibility studies to clinical batch manufacture, PharmSky gives innovators a capable Australian partner for pharmaceutical development services, GMP manufacturing and CMC execution.
As pharmaceutical innovation continues to move faster, sponsors need partners who can adapt quickly, solve formulation challenges and manufacture with rigour. Among CDMO pharma companies, PharmSky is focused on helping innovators move confidently through the development pathway, with the scientific expertise, facilities and regulatory awareness needed to bring better treatments closer to patients.
