Sorry but this page is still under construction, but here is a first impression how MS-Bioanalytics can help to answer questions around bioanalytics in the pharmaceutical industry.
MS-Bioanalytics offers a wide range of consulting and support for your inhouse lab and outsourcing activities.
Setting up a new laboratory needs lot of experience to reach an operational stage as fast as possible. One needs to carefully decide which instrumentation is the most appropriate to reach the goals of the new lab. A good overview on the market and experience can save lots of time and money.
A modern analytical lab needs well a trained staff to handle all different tasks, not only the technology but also the adherence to international standards and regulations (GLP, FDA, ICH, GCP...)
Only a thoughtful planning of the analytics assures that the study results are really meaningful. A wrong decision on the other hand may end with a tremendous loss of time and a repeated study. So which technique is adequate (LC-MS/MS, HPLC-FL...), what LOQ and what calibration range is necessary, which standard can be used, which matrix (blood, plasma, anticoagulant), which storage conditions, maybe a pretreatment of the samples due to stability reasons is necessary?
If you decide to analyze your valuable samples at a CRO you need an experienced analytical chemist to monitor your study. Only this assures that you get the highest possible quality. Independent of the size of the institute problems can occur, starting from delays and ending with fraud. Again each mistake can result in the loss of months during development.
But you have not only to have an eye on the scientific quality of a study, but also to monitor that it is done according to the international standards (GLP, GCP, GMP). In deep knowledge of modern analytical instrumentation and the corresponding software is a prerequisite for audits in analytical labs.
For more information and discussion send an email to: firstname.lastname@example.org