Analytical Services

Analysis tailored for your specific requirements

Analytical testing is a key element of defining your product characteristics and stability.

 

From innovative raw material analysis to finished product release, we offer you the full analytical package of development, validation, and testing services based on your needs and your product's characteristics. Our open-minded team and our flexible approach can help you overcome challenges in development and validation of new and existing methods. Our analytical laboratories work in compliance with cGMP, GLP, and ISO13485.

In addition, our GLP-certified bio-analytical lab offers quantitative bioanalysis services in tissues and biological fluids, to support drug development programs from preclinical to late clinical stages.

Services for you

  • QC services (click here for the full QC tests list).

  • For a full list of our analytical instruments, click here.

  • Development and validation of methods for the determination of the active material concentration in the finished product (Assay).

  • Development and validation of Stability Indicating Methods (SIM) including photostability, sensitivity to acidic or basic conditions, UV radiation, etc. using forced degradation studies.

  • Development and validation of methods for the detection of Impurities and Degradation products (ID).

  • Stability testing including storage in environmentally controlled chambers with 24/7 monitoring for all ICH climate conditions.

  • Development and validation of dissolution and drug release profiling methods.

  • Development and validation of Leachables and extractables methods (the study of potential materials resulting from the interaction between the drug product and its containers).

  • Development and validation of bioanalytical methods for quantitation of active drugs, natural compounds, and metabolites.

  • Testing of tissues and body fluids such as plasma, serum, urine, vitreous fluid, CSF, and cerebral fluid.

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