NCSS has opened a full-cycle R&D center

The National Center of Standard Samples has announced the opening of a full-cycle R&D Center focused on the development of approaches to the synthesis of active pharmaceutical substances (APIs) and the creation of ready-made dosage forms.

The new center forms a single scientific and technological platform that covers all key stages of development, from the development of synthetic approaches and analytical support to scaling processes and preparing technologies for industrial implementation. This format allows projects to be implemented comprehensively, without involving disparate contractors.

The main areas of work include the development and optimization of API synthesis, the formation of an impurity profile, the creation and validation of analytical techniques, as well as the development of dosage forms taking into account biopharmaceutical characteristics.

The Center relies on the scientific and analytical expertise of the NCSS and modern laboratory infrastructure, which ensures high research accuracy and reproducibility of results at all stages of development.

The projects are implemented taking into account the requirements of good manufacturing practice (GMP), pharmacopoeia standards and ICH recommendations, as well as with a focus on the subsequent registration and market launch of drugs.

The opening of the R&D Center is part of a systematic effort to develop a full cycle of pharmaceutical development and strengthen the technological independence of the industry.