Pharmaceutical Analysis Services
In January 2012, LAT GmbH Dr. Tittel Institute for Pharmaceutical Analysis joined the GBA Laboratory Group along with its site in Gräfelfing, Bavaria. LAT GmbH offers comprehensive capabilities in the field of pharmaceutical analysis and is specialized in the following areas:
- EU import checks
- Release tests
- Monographs of reference standards
- Extractables and leachables studies
- Qualified person service
- Capillary electrophoresis
- Regulatory affairs
- Pharmacovigilance
The core competencies of LAT GmbH Dr. Tittel Institute for Pharmaceutical Analysis include not only the standard laboratory services such as pharmacopoeial tests (Ph. Eur., BP, USP), but also stability studies according to ICH guidelines and qualification of reference standards, as well as method development and validating customized analytical methods to qualify und quantify the purity of highly effective drugs (e.g. cytostatics). Other focuses are residue and trace analysis as well as the identification of impurities.
Our pharmaceutical analysis is carried out under GMP conditions. In the field of scientific and strategic project management, LAT offers knowledge and experience from numerous projects in pharmaceutical analysis and regulatory affairs, even in international projects. The portfolio in the field of project support includes the development phase, through its validation and stability test, all the way to the pharmaceutical`s authorization.
In the field of pharmaceutical regulatory affairs, both the process of new authorizations and maintaining existing authorizations have been a part of LAT`s core competencies for more than 30 years.