Food for special medical purposes (FSMP)

Food for special medical purposes (FSMP) is intended for use in patients in hospitals and for patients with special dietary treatment. Therefore, EU regulations, e.g. VO (EU) 609/2013, demand compendial testing of FSMP ingredients. SYNLAb Pharma has a long-term expertise not only for compendial testing of drugs under GMP conditions, but also for food analysis and bioanalytical testing. Together with SYNLAB´s clinical trial support we offer a broad variety of services to our customers from early drug development beyond market approval.  

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

Our Services:

  • Bioassays for release and stability testing (potency assay)
  • Quantification of ingredients and metabolites in various matrices
  • Analysis of biomarkers
  • Developing and implementation of strategies for the analysis of innovative FSMPs
  • Toxicokinetic and PK analysis
  • GMP-release testing of Ingredients and Excipients
  • Physico-chemical testing
  • Compatibility testing
  • Elemental analysis
  • Particle testing
  • Regulatory support
  • Primary packaging material testing
  • Extractables studies, simulation studies, toxicological evaluation, leachables studies
  • Regulatory support
  • Biomarkers: Identification and assay development
  • Analysis from various matrices including serum, plasma, urine, stool, CSF, sputum, tissue, etc.
  • Analytical services for phase I - IV
  • Real-time safety analysis (phase I)
  • Routine lab testing
  • PK/PD incl. method development and validation
  • Biomarkers: Identification and assay development
  • Various matrices including serum, plasma, urine, stool, CSF, sputum, tissue, etc.
  • Immunogenicity strategy: ADA, NAB, including characterization
  • 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
  • Validation of analytical methods for testing of purity, assay and stability
  • 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
  • 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
  • Testing of FSMP Ingredients and Excipients
  • In use stability testing
  • Method development, -validation and -verification
  • Sterility and bacterial endotoxin testing
  • Microbiological contamination testing and identification of microorganisms

For more information

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