Triumpharma’s goal is to achieve a leadership position in the bioanalytical sector through its commitment to serve excellence and technical expertise. All regulatory testing is conducted in accordance with GLP standards and internal SOPs.
The lab is GLP accredited by the JFDA for analysis of clinical trials biological samples.
Triumpharma bioanalytical laboratory has excellent experience in complex bioanalysis for both scientific and regulatory demands, such as high sensitivity assays with pg/ml LLOQ, chiral compounds, light and temperature-sensitive analyses and more, with a very good ISR pass percentage, and in different biological matrices.
The team has experience in handling various small and large molecules and the results generated are as per the CFR compliant which is done by adding strong IT controls for the data integrity part. The Bioanalytical department provides a complete analytical support from the preparation of study plans, through the development and validation of bioanalytical methods, and the analyses of the studied active ingredients and/or metabolites in the collected biological samples.
Triumpharma Clinical Research has a state-of-the-art Bioanalytical Laboratory equipped to cater to a variety of Bioanalytical Research needs at Triumpharma building. All Bioanalytical methods were developed in-house with the innovative thought processes of our expert Bioanalytical team with over 15 years of experience in the industry. Most of the lab staff is holding MS or Bachelor of Science degrees have years of experience in this field and have been associated with Triumpharma since the company’s inception.
The Bioanalytical department comprises a team of experienced analysts and laboratory technicians. The laboratories are equipped with five modern LC/MS/MS devices (API 3000, 4000 and 5500) with triple quadrupoles.
Staffed by highly-skilled analysts, and shifts running 24/7 (as needed), we can process over 70,000 samples per month (depending on the complexity of the analyses).
Bioanalytical methods are developed and validated in accordance with GLP rules and ICH/FDA and EMEA guidelines. So far, more than 100 methods have been developed and validated in the company and the list increases daily. Their overview can be seen in the list of validated bioanalytical Methods.
Your results are quickly delivered since our capacity gives us the ability to analyze over 75,000 samples per month (depending on the complexity of the analyses and our bioanalytical laboratories can perform 50 studies per year (depending on the complexity of the analysis).