We offer the development of analytical and bioanalytical methods as well as verification of the pharmacopeial methods together with validation, both as part of a bigger project of API production as well as the development of a medicinal product and as an independent service.
We develop methods (and perform analyses) within the broad scope of applications within the area of quality control and development of the API technology and the medicinal product:
- batch release,
- API purification and isolation,
- product development,
- analysis of raw and reference materials,
- analysis of bioequivalence, bioavailability and pharmacokinetics.
We also offer support with the transfer, implementation and full support within the scope of revalidating the method.
Both development and validation/ verification of methods are performed in accordance with the recommendations of the International Conference on Harmonisation (ICH), the requirements of the European Medicines Agency (EMA) and the American Food and Drug Administration (FDA).
We offer the possibility to select the method according to which service will be provided: on the basis of procedures submitted by the customer or in accordance with the internal IBA procedures. All works that are being carried out are supplemented with preparation of the relevant documentation: plans, reports, SOP, specifications, certifications of analyses, required documentation when registering a product.
We offer the possibility to perform any method/ validation in accordance with the GLP standard.