Pharmagate® is a support in the regulatory strategy framework at different stages of medical use products life cycle.
The company supports and helps to manage access to the market on territories in the following regions –
• Russia • Ukraine • Belarus • Moldova • Georgia • Armenia
• Azerbaijan • Kazakhstan • Kyrgyzstan • Turkmenistan • Tajikistan
• Uzbekistan • Mongolia
Statandocs today is a multi-profile, dynamically developing company that offers a wide range services that are of high demand within the pharmaceutical industry. For clinical and observational studies (including RWE) we prepare complete essential documents package, support submission process, develop and maintain eCRF and IWRS, conduct validation and statistical analysis of data with preparation of interim and final study report. For registration dossiers (national, EAEU) we prepare all CTD modules, including CTD overview (module 2), assist in submissions, develop and conduct user testing for patient information leaflets, provide cloud service for eCTD XML EAEU for dossier preparation and life-cycle maintenance. We perform pharmacovigilance activities during clinical trials and after market authorization, including development of SOPs, master-file, RMP, conduct literature monitoring and prepare PSURs and DSURs. Statandocs offers various trainings and educational programs both in online format and as face-to-face sessions. Moreover, we actively work in the area of scientific medical writing, preparing materials for physicians and patients, articles (including systematic review and meta-analyses), posters and presentations. Our staff includes over 65 employees, including the highest medical writer head count in the region. We conducted over 1100 various projects for 94 clients in Russia, EAEU and CIS, including big international, regional and local pharmaceutic companies and CROs. Documents and services offered by us are well accepted by regulatory bodies in Armenia, Belarus, Vietnam, Georgia, Kazakhstan, Moldova, Russian Federation, Tadzhikistan, Uzbekistan, Ukraine, and USA. Statandocs is a reliable partner, we evolve rapidly, do not fear the most complex challenges and are at all times ready for productive cooperation.
IQVIA is The Human Data Science Company™ and a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
Proxima Research LLC is part of an international group of companies, which includes key solution-vendors for the life-science industry in CIS countries, covering the complete scope of pharmaceutical companies’ needs in IT-solutions, data for decision-making and product promotion for the last 15 years. Proxima Research LLC provides expert solutions in the area of CRM/ETMS integration and support, HCP/HCO database management, multichannel marketing, BI-solution’s implementation, IT-development, market data, marketing research and consulting.
The company specializes in the development of software products in the field of medicines monitoring, medical devices and medical services. The company has developed and supports the development of 10 large information systems (more than 5,000 objects and over 100,000 users) that solve urgent problems in the healthcare sector. Our solutions operate at the federal level (national registry of medicinal product), regional level (health departments of the constituent entities of the Russian Federation), warehouses, pharmacy chains, local health insurance funds and pharmaceutical manufacturers.
One of the latest solutions is specialized software “Electron” focused on the preparation and maintenance of a dossier (eCTD) for a drug throughout the life cycle, with the possibility of centralized management and monitoring of processes from anywhere in the world, in order to obtain a registration certificate in accordance with EEC rules.
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
Utrace is a leading-edge serialization software solution. We help our clients to meet needs today and build value for tomorrow.
45% of the top 50 pharma manufacturers entrust their business to Utrace.
Advantages of Utrace
1. Reliability
Our clients from the 30 + track and trace projects we have implemented together are all willing to reference us and the success and reliability of our cooperation
2. Combination of legal compliance and the deadlines associated
The largest T&T team in the CIS market, with over 80 specialists and partnership with Governmental T&T Operators allows us to closely monitor all legislative changes and seamlessly implement updates to Utrace subscription to keep our clients up-to-date with all the legal requirements
3. Max level of automation
Track&Trace solution should work as automatically as possible, with a minimum of manual operations and minimum impact on business processes. Utrace automates 145-514% more functions and processes than similar platforms
4. Pharmaceutical industry expertise
We have been implementing serialization projects for global pharmaceutical companies since 2017, so we are fully aware of the business processes and the specifics of the industry. We have accumulated a huge experience, which includes documentation, project methodology, ready-made connectors for integration with ERP, WMS, MES systems. Also, our solutions have repeatedly passed GxP validation according to the GAMP5 standard. All this allows new clients to use our expertise to reduce the cost and duration of project implementation, as well as to minimize risks.
Learn more about the company and our solutions: https://www.utrace.ru/
Janus has remained a trusted partner for customers in the field of life sciences for over 20 years, having demonstrated the translation and localization proficiency required to provide services for global clinical trials, medical devices and healthcare brands, as well as for pharmaceutical, biotech and medical companies.
We provide comprehensive life science translation services to help our customers overcome regulatory hurdles, manage their clinical trials with ease, and succeed in the global marketplace. We offer support in all linguistic areas, from the localization of clinical trial documentation and clinical assessments to regulatory translations for audits or medical devices.
Established in 1994. The Association comprises 60 international pharmaceutical companies that provide over 80% of the world’s pharmaceutical products and over 60% of medicines imported to the Russian Federation.
AIPM Mission
To promote economic and legal policies that focus on the development of organized and open pharmaceutical market, improving of medical services quality and expansion of the range of modern medicines for the benefit of Russian people.
Since 1994 the Mid-Atlantic - Eurasia Business Council (MAEBC/MARBC) has worked to foster business relations between Eurasia and the U.S. Mid-Atlantic region. The goal of MAEBC/MARBC is to enable companies based in the U.S. Mid-Atlantic region to enhance their positions in Eurasia/Russia and to attract Eurasian/Russian businesses to the U.S. Mid-Atlantic region. A major focus of MAEBC/MARBC's efforts has been the establishment of the Mid-Atlantic region as a leading partner for Eurasian - American technology cooperation. The most prominent of the annual events organized by the MAEBC/MARBC are the Eurasian - American Innovation Technology Weeks (RANIT) and Days of Eurasian - American Innovation Entrepreneurship Cooperation.
During the past decade one of the Mid-Atlantic - Eurasia Business Council's main priorities has been Eurasian-American partnership in biotechnology and life sciences. To achieve this goal, MAEBC/MARBC organizes American and Eurasian participation in the most important international life sciences events.
http://www.en.arfp.ru/
http://spfo.ru/
http://sojuzpharma.ru/
https://www.aipm.kz
https://aprfd.kz
https://www.rafm.ru/
The Association of Pharmaceutical Companies «Innovative Pharma» (InPharma) brings together major pharmaceutical companies that actively invest in research and development and are counted among the top 20 global pharmaceutical producers.
Members of the Association have research facilities all over the world and also work with Russian R&D centers to conduct clinical trials, cooperating with more than 250 R&D facilities across Russia. Members of the Association carry out research and development in the key fields of medicine, such as cardiology, endocrinology, psychiatry, neurology, oncology, urology, gastroenterology and diabetology. With a view towards developing partnership for innovative pharmaceutical R&D, members of the Association enter into partnership agreements with the Russian development institutions – the Skolkovo Innovation Centre and the Russian Venture Capital Company, as well as develop projects to modernize the biomedicine and biopharmaceutical sectors in Russia, and invest in the construction of manufacturing facilities and research laboratories.
Interfax is the biggest information group in the CIS and the recognized leader in the B2B segment of Russia’s information market.
Interfax is the most frequently cited source for information on Russia and the CIS in the foreign press.
Interfax develops professional information solutions that help companies operate in the financial and commodity markets, enabling them to reach investment decisions, manage risk, organize external communications and fulfill regulatory requirements.
https://www.pharm.reviews
http://www.pharmnews.kz/
http://gmpnews.ru/
http://www.con-med.ru/
http://www.pharmvestnik.ru/
https://promoboz.com/
Remedium group of Companies renders the whole range of services for specialists in the field of medicine and pharmaceutics. For years the principle directions of activity of “Remedium” Group of Companies are publication of particularized periodicals, assignment of electronic databases, arrangement and implementation of measures, rent-a-rep service, organization of advertisement and PR support.
https://pharmjournal.ru/
http://mosapteki.ru/
https://aptekamos.ru/
https://www.strizhmedia.ru/
https://фармпром.рф
National Pharmaceutical Journal
http://www.medsovet.info/
http://pharmmedprom.ru
https://fp.com.ua
https://www.modern-pharmacy.com.ua/