Method Development, Transfer and Validation

Whether you need expert testing consultation, method development or validation protocol design, Eurofins Sinensis offers you the widest range of laboratory techniques in the industry. We support customers at various stages of the development / validation process and have a proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods.


Method Development and Validation Services for:
 

Chemistry/Biochemistry

  • Assay/Potency, Purity/Impurity, Dissolution
  • Cleaning Validation Analysis (Specific and Nonspecific analyses)
  • Assay, Impurity and Dissolution methods for Comparator products
  • Residual/Impurities Testing
  • Stress Testing
  • Complaint vials
  • Excipients
     

Microbiology

  • Bacteriostatis/Fungistatis for Sterility
  • Inhibition/Enhancement Screening for Endotoxin
  • AET and Microbial Limit
     

Molecular and Cell Biology

  • Cell-based Assays
  • ELISA
  • qPCR
     

Why Choose Eurofins Sinensis?

  • Dedicated project leaders collaborate closely with our customers to generate compliant protocols in accordance with ICH guidelines.
  • Quick turnaround time on feasibility assessment of the methods, execution of the protocol and generation of the final report.
  • A flexible process that allows on-site training at our laboratory or travel to the client site for more complex and/or technique-based methods.
     

If you have any questions regarding our services, please do not hestitate to contact us to find out whether we can help.

  • Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
  • All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
  • Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.

Questions? Call us now

+31 (0)71 524 4080