News
Dr Lluïsa Garcia advises on how to manage N-nitrosamine impurities in sartans
“Face Nitrosamine uncertainty with a flexible analytical CRO and a full risk assessment” Dr Lluïsa García, Kymos Pharma Services There has been much attention surrounding the discovery of N-nitrosamine impurities in blood pressure medicines known (...) Read more
What happens to batch testing and batch release after Brexit
Kymos complies with FDA & EMA inspections as well as GLP, GMP and GCP standards. In particular, as a GMP certified CRO, we take the responsibility tosupply manufacturer authorisation for quality control purposes. In this (...) Read more
Host Cell Proteins Analysis
The development and validation of a process specific assay for host cell proteins (HCP) determination in therapeutic recombinant proteins should follow the specifications contained in monograph 2.6.34 of the European Pharmacopeia in a step by (...) Read more
Quality and Equivalence of Topical Products
On October 18, 2018 the EMA published the Draft Guideline on Quality and Equivalence of Topical Products. On June 30, 2019, the period of Consultation will end and it is expected to be in force (...) Read more
