Pharmaceutical CDMO
United States
Maximise Your R&D Budget with Up to 43.5% in Tax Incentives
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
Your Advantages
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)
Companies conducting R&D in Australia, including clinical trials and drug development, may be eligible for a rebate of up to 43.5%.
We help map activities, ensure documentation, and maximise your return.
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…
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…
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.
Controlled Substances
In an era marked by advancements in pharmaceuticals and medical treatments, handling of controlled substances and highly potent drugs demands precision, expertise, and an unwavering commitment to safety and compliance.
Contact Us Today
Fast track your development with our extensive services. Get in touch so we can discuss your requirements.
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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..
