Complex Generic Drugs: What They Are and Why They Matter
Generic drugs have played a critical role in improving global healthcare by providing cost-effective alternatives to brand-name medications. However, as […]
Ensuring Regulatory Compliance in Pharmaceutical Manufacturing: A Guide to GMP and Quality Control
Regulatory compliance in pharmaceutical manufacturing is essential to ensure that drugs are safe, effective, and of high quality. Compliance with
The Role of CMC in Drug Development: Why It’s Critical for Regulatory Success
Ensuring the quality, safety, and efficacy of pharmaceutical products is essential for gaining regulatory approval and bringing a new drug
Analysing MCPD, Glycidol and their Fatty Acid Esters
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…
Assessing Nitrosamine Impurities In Your Pharmaceutical Product
NITROSAMINES IN PHARMACEUTICALS Nitrosamine impurities are potential mutagenic carcinogens that present a major safety concern even at trace amounts. Several
Manufacturing Scale Up for Clinical Trials
PharmSky Research was contracted by a client to manufacture Phase 1 clinical material of a novel, fatty acid based topical
TGA License Granted
Exciting news! Thrilled to share that PharmSky Research have officially received the Therapeutic Goods Administration License. A testament to our commitment to quality and
Sameer Agarwal Appointed to Board of Directors
We’re excited to announce that Sameer Agarwal was recently appointed as a Member of PharmSky’s Board of Directors. Sameer brings
Quantitation of Trace-level Carcinogens Using GC-MS/MS
PharmSky was challenged to detect the three impurities down to trace levels (ppb) for a client interested in the development
PharmSky’s Robust, User-Friendly & Cost-Effective LC Methods
PharmSky was challenged to develop an Analytical Method for a client to characterise a small, polar molecule with poor UV
