In conditions of сonstant market changes, CSC Pharma has announced the development of a new separate area of its activity. 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, — is stressed by CSC Pharma. — Some companies are reducing their personnel presence, entrusting part of the tasks to 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 the partner in the form of a service regulatory contract.
«Actually contractual regulatory activity is not a new sphere to CSC Pharma, — explains Sergey Beloborodov, CSC Pharma General director. — 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».
«Historically, the company’s portfolio includes pharmaceuticals of several original foreign companies, for whom we have been supporting the registration dossier for decades, —Viktoria Andreyeva, Head of Medical division, added — 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».
During the company’s existence, about 30 new medicines have been introduced to the Russian market and the CIS market, the number of approved variations in the dossier is in the hundreds, GMP audits of dozens of factories of various companies have been passed, she said. Now the company’s portfolio has become more diverse and includes several dietary supplements and medical devices.
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. «Our team confirmed its strategies with subsequent results, which are expressed in sales of our products in the territory of the EAEU, — they mentioned in CSC Pharma. — By results of 2021/2020 years CSC company entered the TOP 10 corporations in terms of growth in the retail commercial market in value terms (data provided by Alpharm*).”
CSC Medical division staff have labour experience not only as employees of the commercial company, but in the past, they were also employees of state bodies and subordinate institutions 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, the Company added. CSC Pharma is ready to share these knowledges with the partners and to carry their medicinal product through the authorization procedure with issuing of certificates in the shortest possible time.
Among the companies, which receive services from CSC Pharma are Almirall, Angelini, Dompé, Italfarmaco, Alfa Wasserman, Recipharma, Baldacci, BMG, Devicare. “We take care of every project because we associate the timing and quality of regulatory decisions with the commercial future of the product,” the company concluded.
*The data of CSC Pharma, based on the studies of Alpharm.