How CMC Impacts FDA and TGA Approval
A strong clinical result can create real momentum for a pharmaceutical product, but it’s only one part of the approval […]
A strong clinical result can create real momentum for a pharmaceutical product, but it’s only one part of the approval […]
PharmSky recently had the opportunity to work with Channel 10, providing analytical testing services to support their investigation into illegal
PharmSky Research is heading to BIO-Korea! 📍Coex, Seoulđź—“27 – 30 April Our Director of Business Development, Murali Nair, will be
Analytical method validation is essential to pharmaceutical development. It confirms that each test method produces reliable and reproducible data, supporting
Regulators require drug product manufacturers to identify and quantify extractables and leachables so that their impact on patient safety and
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…
NITROSAMINES IN PHARMACEUTICALS Nitrosamine impurities are potential mutagenic carcinogens that present a major safety concern even at trace amounts. Several
PharmSky Research was contracted by a client to manufacture Phase 1 clinical material of a novel, fatty acid based topical
Exciting news! Thrilled to share that PharmSky Research have officially received the Therapeutic Goods Administration License. A testament to our commitment to quality and
We’re excited to announce that Sameer Agarwal was recently appointed as a Member of PharmSky’s Board of Directors. Sameer brings