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Selvita S.A. services
Discovery Services - Structural Biology
Selvita - Structural Biology
Department of Biochemistry has long-standing expertise in supporting development of biologically active chemical compounds for multiple pharmaceutical, agrochemical and biotech companies. Extensive know-how combined with highly skilled and goal-oriented scientists is a perfect combination enabling a successful execution of your project.
Selvita - X-ray Crystallography Service
We offer crystallography services from protein production and crystallization to data collection and structure determination, with streamlined protocols and guaranteed reproducibility.
Regulatory Studies Services
Selvita - Analytical Method Development and Optimization Services
Development and optimization phases during the drug life cycle are crucial. We’re fully aware of that fact, and we work in an efficient and flexible manner, using the best industry practices, in order to support our clients at this important stage of the process. Our team consist of industry experts with a thorough understanding of the process and long-standing expertise in the field, complemented with appreciation of the latest trends in analytical and bioanalytical chemistry.
Selvita - Functional Assays Regulatory Studies Services
Selvita offers state-of-the-art functional assays to assess binding to target antigen and FcγRs and complement with SPR (on-off kinetics) and ELISA along with tailored cell-based potency assays to assess Fab-associated functions and ADCC and CDC assays to measure Fc-associated functions.
Selvita - Stability and Forced Degradation Studies Services
Selvita offers a comprehensive set of services related to the stability studies for different formulations, drug substances or drug product with different dosage forms. The scope of stability studies offered includes preparation of a stability study protocol, study monitoring and a complete analytical testing needed for particular drug, continuous and summary reporting of stability results.
Selvita - GMP Analytics and Quality Control Service
Quality control is an integral part of the drug production process. Selvita specializes in the final stage of quality control of pharmaceutical products (small and large molecules) – routine analyzes of batches for release (release testing).
Selvita - Regulatory Aspects Support Service
In addition to laboratory work, Selvita can also support its clients in other areas. Our team of experts can provide our clients with help in many regulatory aspects such as: Chemistry Manufacturing and Controls (CMC) documentation preparation, filling in the quality module in the Common Technical Documentation (CTD), as well as, batch certification (certificates of analysis and certificates of confirmation) confirmed by the Qualified Persons employed by Selvita.
Drug Development - Small Molecules
Selvita - Small Molecules: Method Development, Validation, and Transfer Service
Development, optimization and qualification phases are crucial during the drug life cycle. At Selvita we work in efficient and flexible manner, using the best industry practices, in order to support our clients at this important process stage. Our team consists of industry experts with a thorough understanding of the process and long-standing professional expertise in the field, complemented by appreciation of the latest analytical and bioanalytical chemistry trends.
