SYNLAB Analytics & Services Germany GmbH is a service-based partner for the international pharmaceutical and biotechnology industry.
We provide fully GMP-compliant analytical services and are an FDA registered laboratory.
The analytical focus of SYNLAB Analytics & Services Germany GmbH is on structure elucidation using state of the art equipment using LC-MS/MS, LC-Q-ToF-MS, SPME GC-MS, GC-MS, NMR/ qNMR, semi and fully preparative HPLC, isolation and synthesis of degradation products in drug substances and products.
In addition, we offer characterization and qualification of reference standards, planning and execution of extractables & leachables studies and toxicological assessments of contaminants.
Method development and method validation and release analysis give our customers the full quality-control package needed for clinical studies and filing. Our analytical experts guarantee a quick and target oriented solutions beyond standard.
Clinical Trial Services
SYNLAB Pharma develops and implements strategies for the analysis of innovative products, biosimilars and biobetters. Only to name some areas of expertise: PK and PD, biomarkers and immunogenicity including assay development, optimization and validation. In addition, the drug production proccess is supported by our broad experience in running bioassays for release and stability testing.
SYNLAB pharma provides real-time lab testing (24/7) of safety panels for several phase I units. In addition, PK/PD testing and a broad spectrum of biomarkers in various matrices (serum, plasma, urine, sputum, stool or CSF) is available.
For phase II and phase III studies central routine lab testing for the evaluation of safety and patient in/exclusion criteria is provided as well as advanced analytical services for efficacy evaluation.
Another core service of SYNLAB Pharma is stability studies in accordance with ICH Q1A(R2), including consultancy, planning, storage and analysis. SYNLAB Pharma supports all stages of successful drug product registration: Long-term, intermediate and accelerated stability; ongoing and follow-up stability studies, stress testing (including photo-stability testing), and compatibility studies.