SYNLAB Pharma has a long-term expertise not only for compendial testing of drugs under GMP conditions, but also for special analytical tasks, e.g. method development, impurity characterization and biomarker analyses. We support our customers with a combination of preclinical capabilities together with SYNLAB´s clinical trial services for innovative cosmetics.

SYNLAB Pharma holds certifications for GMP, GLP, GCP and GLCP to cover the whole range from batch release to clinical trial support.   

Our Services:

  • Testing of Ingredients and Excipients
  • In use stability testing
  • Method development, -validation and -verification
  • Sterility and bacterial endotoxin testing
  • Microbiological contamination testing and identification of microorganisms
  • Environmental monitoring
  • Compendial (USP, EP) & non-compendial testing
  • Physico-chemical testing of ingredients and excipients
  • Stability storage and testing
  • Cleaning validation
  • Elemental analysis
  • Particle testing
  • Spectroscopic testing (IR, UV, NMR)
  • Regulatory support
  • Check of identity, content, purity, and robustness
  • Validation in accordance with ICH Q2(R1) or based on client demands and equipment (assay and identification)
  • Accuracy, precision, specificity, LOD/LOQ, linearity and range
  • Limit test and quantification
  • Validation protocol and report
  • Method transfer
  • Customized method development for testing of purity, assay and stability 
  • Extractables studies, simulation studies, toxicological evaluation, leachables studies
  • Studies are carried out in our GMP laboratory according to the most recent guidelines
  • Stress tests and compatibility studies of packaging materials are included
  • Analysis of substances with unknown biological and toxicological effects
  • Analysis of contaminants in Ingredients and Excipients and degradation products during stability studies
  • Preparative isolation of contaminants
  • Risk analysis and toxicological assessment (PDE-Data)
  • Elemental impurities screening (ICHQ3D)
  • Synthesis of non-compendial reference standards, including complete characterization
  • Preparative isolation of impurities with complete characterization
  • Storage, packaging and shipping of reference standards
  • Submission of a Certificate of Analysis (GMP) for reference standards
  • Storage of stability and stress samples under controlled ICH-conditions
  • Analysis of samples using state-of-the-art equipment according to the established stability protocol
  • Quantification of ingredients and metabolites in various matrices
  • Analysis of biomarkers
  • Biomarkers: Identification and assay development
  • Analysis from various matrices including serum, plasma, urine, stool, CSF, sputum, tissue, etc.
  • Developing and implementation of strategies for the analysis of innovative products
  • Toxicokinetic and PK analysis
  • Analytical services for phase I - IV
  • Routine lab testing
  • PK/PD incl. method development and validation
  • Support of multi-national or global clinical trials
  • Visit-specific kits and study-specific lab manuals
  • Transportation logistics for ambient, cooled and frozen samples
  • Customised project and data management

Für weitere Informationen

Kontaktieren Sie uns