Melbourne,
Australia’s Own Pharmaceutical CDMO
Providing Specialised Services In:
Fast tracking the development of unique
biopharmaceuticals for a healthier tomorrow
Our formulation and product development services follow a streamlined, systematic approach aligned with regulatory guidelines to ensure quality is built into the development strategy.
Analytical and characterisation methods are developed and validated to suit each relevant stage of development, ensuring reliable and robust data every step of the way.
We have the capacity to manufacture and provide medicinal products to support pre-clinical trials and develop product to pilot scale to support manufacture for Phase I clinical trials.
Our regulatory team includes members with over 25 years experience in global product registration in the US (IND, NDA, ANDA, 505b(2)), Europe, Asia, South America and ROW.
Process-related impurities originating from oil refinement The Problem 2- and 3-monochloropropanediol esters (2-MCPDE and 3-MCPDE) and glycidyl esters (GE) are impurities that form at high temperatures during the oil refining process. During digestion, 2-MCPDE, 3-MCPDE…
Continue Reading →NITROSAMINES IN PHARMACEUTICALS Nitrosamine impurities are potential mutagenic carcinogens that present a major safety concern even at trace amounts. Several drug products have been recalled from the market due to unacceptable levels of nitrosamine contaminants.…
Continue Reading →PharmSky Research was contracted by a client to manufacture Phase 1 clinical material of a novel, fatty acid based topical product for the treatment of viral shingles. PharmSky worked closely with the client to ensure…
Continue Reading →Exciting news! Thrilled to share that PharmSky Research have officially received the Therapeutic Goods Administration License. A testament to our commitment to quality and compliance. Grateful to the Pharmsky team for all their hard work to make this possible.…
Continue Reading →102 Fox Drive, Dandenong South
VIC, 3175, Australia
Monday – Friday: 9am – 5pm
Saturday – Sunday: Closed
PharmSky Research 