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chemical development services

ANAYLTICAL CHEMISTRY SERVICES FOR PHARMA

 

Selvita offers a very wide range of services in the area of anaytical chemistry. We have managed to assemble a unique team of top class specialists in the field of physicochemical analysis and highly skilled professionals with broad experience from pharmaceutical industry.

The range of our services in this field includes:

  • Development validation and verification of analytical methods
  • Evaluation of API suppliers
    Selvita supports our customers during the process of evaluation of active pharmaceutical ingredient (API) suppliers. Our laboratory provides a package of analytical services for qualitative assessment of APIs.
  • Cleaning validation
  • Detection of residual solvents
    According to EMEA and FDA guidelines residual solvents are a specific group of impurities. Due to the lack of therapeutic effect, solvents present in the API should be reduced to the lowest level possible, that is defined in the relevant guidelines. Selvita offers API analysis and determination of the content and concentration of residual solvents by means of GC/MS.
  • Proteomics and pharmacokinetics
  • Evaluation of pharmaceutical availability
    Drug pharmaceutical availability evaluation is extremely important not only at the stage of drug quality control but is also an indispensable research tool in the process of developing a novel drug formulation. Selvita's highly qualified staff performs those analysis using appropriate modern laboratory equipment.
  • Impurity profile determination
    Thanks to the state-of-the-art facilities and laboratory equipment Selvita offers stability study and impurity profile determination of the active pharmaceutical ingredient (API). Those results might be supplemented by the genotoxicity study of the identified impurities.
  • Genotoxicity studies
  • Analytical assays required for clinical trials
    Selvita offers comprehensive services related to testing of drug bioequivalence that require a complex approach. State-of-the-art facilities and software used in these studies enable Selvita the identification of drugs in biological material with the highest sensitivity, precision and specificity, as well as the determination of pharmacokinetic parameters that are indispensable in evaluating drug bioequivalence.
  • Drug registration dossier
    Selvita offers support in the preparation of registration dossiers in accordance with the CTD format requirements of the International Conference on Harmonization (ICH).