Drug Medical Device Analysis Laboratory
As the Pharmaceutical & Medical Device Laboratory, we provide GLP approved and ISO 17025 accredited services in the pharmaceutical and medical device sector. For the pharmaceutical sector, we offer services in Elemental Impurity, Nitrosamine Impurity, Analytical Method Validation, Extractables & Leachable Studies, and Uncertain Peak identification processes. For the medical device sector, we provide services in Chemical Characterization, In vitro - In vivo Biocompatibility, Cleaning Validation, Microbial Contamination processes.
Product-specific analysis methods are developed in the pharmaceutical analysis laboratory, and validation and verification services are provided. Our studies follow the ICH Quality Guideline (ICH Q14) for analytical procedure development, and the validation procedures are verified based on the ICH Q2(R2) guideline.
Our aim is to add value to the industry and to carry out all necessary analyzes and tests in accordance with international standards. We are constantly working to provide you with the best service and keep up with developing technology.
