Pharmaceutical CDMO
in Melbourne, Australia
Fast tracking the development of unique biopharmaceuticals for a healthier tomorrow
Realise your vision. Partner with PharmSky.
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
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Over 25 years experience in drug product development, complex formulation, injectables, regulatory and intellectual property space.
PharmSky is a pharmaceutical contract research organisation with a focus on drug development based in Melbourne, Australia. Established with a vision to provide innovators across Australia and around the globe a launchpad to transform ideas and discoveries into registered, tangible products ready for market.
Our local leadership team members each hold over 25 years experience in drug product development, complex formulation, injectables, regulatory and intellectual property space.
