CSC Pharma. Regulatory support of registration processes.

In an ever-changing market, CSC Pharma announced the development of a new separate line of its activities in 2022. This is regulatory support of projects in the sphere of registration of the pharmaceuticals, medical devices, food supplements, and cosmetic products.

Epidemiological situation of the several last years, and now also the sanctions in some branches of economy directly affect the pharmaceutical companies prompting them to work out good strategy for registration of their product. Some companies are reducing their personnel presence, entrusting part of the tasks to the Russian partners. For some manufacturers, the volume of projects exceeds their own strength. When this is the case, CSC Pharma, independent private company with 30-year experience is ready to propose a strategy for the regulatory process, define the stages and form an appropriate offer for a partner in the form of a regulatory service contract..

CSC Pharma Experience /Team

«Contractual regulatory activity is not a new sphere to CSC Pharma, — explains Sergey Beloborodov, CSC Pharma General director, in his interview to “Pharmvestnik”, information-analysis portal.
— For many years we have been successfully solving these tasks for our partners. But today, responding to the growing needs of the market, we start providing regulatory services even in the absence of a commercial contract for the drug market launch».

«In recent years, a significant number of launches and new regulatory requirements have created a fresh impetus for the development of the CSC Pharma regulatory division. Today we see our maturity and competence and provide services in conditions of strict requirements of service contracts,
—Viktoria Andreyeva, Head of Medical division, added
— During the company's existence, about 30 new medicines have been introduced to the Russian market and the CIS markets, the GMP-audits of dozens of pharmaceutical plants of various companies have been passed. Now the company's portfolio has become more diverse and includes several dietary supplements and medical devices».

Advantages of Cooperation

Often, the strategic plan for bringing a drug to the market can take several years, and it is important not to make a mistake when choosing the size of research, amount of documents and materials of the registration dossier, audits and inspections of pharmaceutical plants, which will become sufficient later, during registration. The CSC team confirmed its strategies with subsequent results, which are expressed in sales of our products in the territory of the EAEU.

CSC Medical division staff have labour experience as employees of the commercial companies and subordinate institutions of state bodies in the field of healthcare, have scientific degrees in the field of pharmaceuticals, as well as practical work experience at Russian manufacturing enterprises in the development and quality control departments.

Among the companies that applied for regulatory aid from CSC Pharma are Almirall, Dompé, Italfarmaco, Recipharm, Baldacci, BMG, Devicare and others.

"We take care of every project, because we associate the timing and quality of regulatory decisions with the commercial future of the product".