SYNLAB Analytics & Services Germany GmbH

Booth number 2008-1

www.synlab.de/pharma

About us

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.

Products and services

Clinical Trial Services

  • 24/7 lab service for Phase I trials

  • Safety panels and hematology

  • Full analytical spectrum

  • Genetics and PCR

  • Microbiology and bacteriology

  • Histopathology and cytology

    Bio-Analytical Services

  • PK/PD drug assays

  • Structure elucidation

  • Identification of metabolites

  • Small / large molecules

  • Bioassays

  • Cell based assays

  • Immunogenicity

    GMP Analytical Services for Drug Products and Drug Substances

  • Release testing according to Pharmacopeia (EP/USP)

  • GMP storage

  • Stability testing according to ICH guidelines

  • Microbiological testing/ bio burden

  • Leachable & extractable testing

  • Heavy metal determination to ICH Q3D

  • Method development and validation for assay and impurity testing

  • Handling of controlled substances
Bio-Analytical 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.

Clinical Trial Services

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.

Stability and release testing

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.

Address
SYNLAB Analytics & Services Germany GmbH
Auf der Huels 183
52068 Aachen
Germany

Phone: +49 241 4757360
Fax: +49 241 47573629
Internet: www.synlab.de/pharma
E-mail: Send message

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