Laboratory
In December 2023, construction of NCSS's new laboratory complex was completed, significantly expanding the company's capabilities in the development, certification, and production of reference materials for active pharmaceutical ingredients (APIs) and their impurity compounds.
With the commissioning of the new complex, NCSS began fulfilling commercial orders for medicinal product quality control, as well as conducting research and development (R&D) work in accordance with international standards.
The laboratory is equipped with advanced analytical systems from leading global manufacturers, ensuring high accuracy and reproducibility of results.
Studies for drug development and registration
Preclinical studies
Ex vivo studies (cell and tissue cultures), in vivo studies (in animals), and in silico studies (computer modeling) to obtain data on the safety and biological efficacy of drug candidates.
Clinical studies
Pharmacokinetic and immunogenicity studies within bioequivalence trials and early-phase clinical research.
Quality control services
Development, validation, and verification of regulatory methods
Development and validation of methods for assay, identity, dose uniformity, impurity control, and dissolution for regulatory documentation. Includes expert consulting and independent method review before dossier submission.
Comparative dissolution kinetics test (CDKT)
Comparative dissolution kinetics testing required to select a reference product batch for subsequent bioequivalence studies.
Biowaiver
CDKT, CDKT validation, and biopharmaceutical solubility assessment for registration of medicinal products under the biopharmaceutics classification system (BCS) within the biowaiver procedure.
Dietary supplement quality control
Quality control studies for dietary supplements, including trace elements (ICP-MS), vitamins, heavy metals, and quantitative determination of compounds (HPLC-UV and HPLC-MS/MS).
Certification and quality management
The NCSS testing laboratory operates in compliance with EAEU Good Manufacturing Practice requirements (certificate No. GMP/EAEU/RU/01520-2024) and the ISO 9001:2015 quality management system requirements (certificate No. S10020132).
Materials and staff
All consumables and reagents meet quality requirements and are sourced from trusted suppliers. Our laboratory staff comprises highly qualified specialists with extensive quality control experience. All employees undergo regular training and professional development, enabling them to apply the latest analytical methods, deliver objective results, and find solutions to complex analytical challenges.
Need a consultation?
For detailed information about our laboratory services, please contact us via email or phone.