Registration of medicines
To date, all that is related to the registration of medicines in the Russian pharmaceutical market is regulated by the Federal Law of 12.04.2010 N 61-FZ "On the circulation of medical products." Specialists of our company, guided by the law, are fluent in the material and that is why our company can guarantee its customers high quality consulting services and project support for registration and bring to market drugs and pharmaceutical substances, including for veterinary applications.
Handling of medical devices is regulated by Federal law N 323-FZ of 21.11.2011 "On the basis of public health protection", and certain types of products that pose a potential hazard to humans - Federal Law N 52-FZ of 30.03.1999 "On the sanitary and epidemiological welfare of population "and the Federal Law N 29-FZ of 01.02.2000" On the quality and food safety." In this legal framework is constantly making changes and additions.
In today's world pharmaceutical market and all of medicine as a whole has completely passed on the basis of the evidence, that is, any statement, method, indications, contraindications, and other characteristics of the drug or treatment can "assign" only proving their validity and truthfulness. Thus, to prove the safety of a new drug it first investigated in laboratory animals (preclinical studies), and only by proving that the drug is safe for humans potentially could continue his studies. That is why one of the main specialization of our company is to organize, conduct, monitoring and enforcement of the various studies in the pharmaceutical field - pre-clinical studies, clinical trials of all phases, including bioequivalence studies and postmarketing observational studies. We provide a service, "a study on the key", ie, we take on the entire process, from the preparation of documentation and to write a report on the study, and individual service that your company needs.
Our company employs professionals who have extensive experience in the development of documentation, such for example as the study protocol for the proper and effective conduct of the clinical study. Those carrying out the monitoring of clinical trials in our company are properly trained and have not only the experience but the qualifications and certificates.
Analysis of medicines market in Russia
Access to the new, unfamiliar to the company, market outlet, is always a high risk and complex task. The decision on bringing of its products into a new market is not taken spontaneously and should be based on the data enabling to predict with a high probability the further development of the life of the product.
Market analysis is a complex, time consuming and multistep process that requires experience, knowledge and established contacts that enable in the shortest time span to collect, compile and analyze statistical, economic and other related data and to form a unified, detailed expert report, which allows to design lines of conduct and build forecasts. We carefully check all data used in our work that allows us to guarantee the reliability and accuracy of the information we provide.
Conducting of marketing research
In today's market conditions, one of the main ways to increase the profitability of the product is properly conducted marketing research and implementation of marketing strategies based on it. Another factor increasing the profitability of the product is its innovation, but in the case of the pharmaceutical market, even an innovative product requires that physicians and patients were informed about it, its advantages and disadvantages.
Clients of RusClinic CRO receive a wide range of capabilities: networking with potential partners and customers - patients, physicians and opinion leaders. We assist our clients in the organization of conferences with leading experts, and preparation of marketing presentations and brochures.
Distribution of medicines
The main goal of any pharmaceutical company that comes to us for assistance in registering the medicinal product (or pharmaceutical substance), clinical or preclinical studies, market analysis and marketing research, is to sell its products to end users. That is why our range of services includes also distribution of medicines.
Development of normative documents
Most companies come to us, with a complete or almost complete package of documents required to undergo registration procedures in the relevant competent authority. However, in the modern realities an increasingly popular service became the development of the normative documentation on the medicinal product or a pharmaceutical substance.
RusClinic CRO can help to develop normative documentation (ND) or Manufacturer's monograph (MM) for your products, to develop analytical techniques and to validate them in accredited laboratories. We can make the Basic Prescribing Information (BPI) appropriate to all modern requirements, of a medicinal product, based on information about similar preparations (for generics), reports of clinical trials (if any) or organize ourselves clinical studies which are necessary and sufficient for drawing up Basic Prescribing Information.
Audit of registration activity
We offer a service to domestic and foreign companies - an independent audit of the registration of a branch or a representative of your company in Russia, the efficiency of the department for registration of medicines in your company or a particular group of employees, which will lead to a detailed report on registration activity undertaken by the staff of your Russian office.