Mission and Purpose

National Center of Standard Samples LLC (NCSS) is a 100% subsidiary of the Federal State Institution "State Institute of Drugs and Good Practices" (FSI "SID & GP") under the Ministry of Industry and Trade of the Russian Federation.

Pursuant to an order from Rosstandart (the Federal Agency for Technical Regulation and Metrology), the FSI "SID & GP" has been designated as a participant in the State Service of Reference Standards. It has authorized NCSS to perform the full cycle of operations to supply the Russian pharmaceutical and medical industry with high-quality Certified Reference Materials (CRMs).

NCSS's activities are focused on strengthening the country's technological sovereignty, reducing import dependency, and enhancing the resilience of domestic pharmaceutical manufacturing.

The Role of Reference Standards in the Pharmaceutical Industry

Reference Standards (RS) are benchmark materials that play a critical role in quality control at all stages of drug manufacturing. They are essential for analyzing both active pharmaceutical ingredients (APIs) and finished dosage forms.

Reference Standards are used for:

  • Identification and quantification of pharmaceutical substances.
  • Conducting research and development for new drugs.
  • Performing pharmacokinetic and chemical-toxicological studies.
  • Environmental monitoring at production sites.

The development of control methods using Reference Standards enhances oversight by both manufacturers and regulators.

Challenges of Import Dependency and the Advantages of a National RS System

Prior to the establishment of NCSS, Russian pharmaceutical manufacturers had to rely on Reference Standards from the US and European Pharmacopoeias (USP, EP), which created a number of systemic risks:

  • Logistical Risks: Long lead times (from several weeks to six months) and disruptions in global supply chains.
  • Economic Risks: High and volatile costs, driven by exchange rate fluctuations and distributor markups.

The creation of a national Reference Standards system mitigates these risks by providing manufacturers with accessible, high-quality reference materials delivered in a timely manner.

Key Competencies and Services of NCSS

The Center possesses all the necessary competencies for the full lifecycle management of Reference Standards:

  • Development and certification of new Reference Standards.
  • Testing and determination of metrological characteristics.
  • Production and supply of CRMs to domestic manufacturers.

Cooperation Terms and Competitive Advantages

NCSS offers pharmaceutical companies flexible and advantageous cooperation terms:

  • The ability to order the required volume of a specific CRM batch without commitments to large minimum orders or annual advance payments.
  • If a required Reference Standard is not in our portfolio, the Center will develop and certify it.
  • Complete elimination of logistical risks and long waiting times.
  • The price of domestic Reference Standards is fixed and significantly lower than that of imported equivalents.

The activities of National Center of Standard Samples are aimed at creating a stable, independent, and competitive system to supply the domestic pharmaceutical industry with critically important Reference Standards. Cooperation with NCSS allows drug manufacturers to optimize costs, improve the reliability of their production processes, and strengthen their position in both domestic and international markets.