Drug registration in Russia
is the result of a rather lengthy and complex process. It starts with the submission of an application to the Ministry of Health of the Russian Federation for state examination.
When conducting specialized examination, the evaluations of the potential benefits of the drug and the consumer’s risk of use, as well as the quality control of the drug is conducted
Permits are issued if risks are permissible and comply with Federal Law No. 61-FZ “On the Circulation of Medicines”, which has been in effect since 2010
obtaining permits is only the beginning. After that, pharmaceutical companies need to promote a novelty, and this happens in a fairly tough competition. Without knowledge of the market and all the processes occurring in the pharmaceutical field, the task is difficult.
Assistance in the registration and promotion of medicines in the Russia
On the territory of the Russian Federation in accordance with the law are subject to state registration:
Combinations of already registered drugs
All variations linked with the drug form & dosage
As a rule, manufacturers or their official dealers prefer not to deal with the procedure themselves. They apply to companies that professionally provide regulatory services in Russia (registration with regulatory authorities), which are involved in the process of obtaining permission for medical use of the drug in the Russian Federation and its further promotion.
Appealing to professionals is associated with problems. They are the same, and all manufacturers and their dealers have to face them. These are:
- deception — failure to fulfill their obligations
- delay in time, because of which the service becomes unprofitable
- lack of information on the process of obtaining permits
- the requirement of advance payment of 100%, and the result — 100% fraud
Described only part of the negative situations. They are much more. Each damages the patent owner and his representative.
If you do not want to face even a minimal problem, contact Expert Pharma Group
For over 10 years we have been engaged in obtaining permits/registration certificates for medicines in Russia and their promotion. We know all the details of the process.
Never let down customers!
Professional consulting and drug registration in Russia
Contract-research organization in Russia Expert Pharma Group (EPG) provides consulting services for the registration and promotion of medicines in the Russian Federation. Among our services:
- marketing evaluation of pharmaceutical market
- conduct of clinical trials (CT)
- registration of finished products, API, Food supplements
- obtaining Russian GMP certificate
- promotion and commercialization of drugs
A team of a few dozen professionals promptly and efficiently performs all tasks, including the most complex. During the period of work in the core market niche, we have successfully completed over 400 projects.Annually:
receive registration certificates more than 5
conduct clinical trials more than 10
carry out GMP certification more than 4
There are customers in our customer base who continue to use the services of EPG since the company’s foundation — for more than 10 years. We thank them for their loyalty to us as a service provider
We provide comprehensive information and consulting support
We are glad to recommendations that our clients give to their surroundings
According to reviews, our services help to double the turnovers!
Never disappoint our customers!
Services in the field of drug registration in Russia
Specialists provide a full range of services — from drug selection and consulting on drug registration in Russia to assistance in promoting and organizing sales. Order both one-time and complex turnkey services when bringing drugs to the Russian market. Among the services of the company:
- registration of medicines in stages and pharmaceutical substances
- clinical trials of drugs
- Bioequivalence (BE) studies in Russia
- assistance in the development of the pharmaceutical business in Russia
- variations in existing documents
- GMP certification and other specialized services
Quickly and efficiently perform tasks of any level of complexity and volume.For you:
staff experience in the market niche
high reputation of the company
knowledge of all specialized processes
established personal contacts
All this and many other factors in the optimal combination allow the experts of Expert Pharma Group register drugs while selecting the most cost-effective, time-saving, and efficient ways.
Minimizing the likelihood of failures even during the initial submission.
Features of interaction and pricing
In addition to professionalism, our customers especially note the high speed of performing tasks: it is 2 times higher than the average for the market.
Attract adequate prices for registration, promotion and commercialization of drugs in Russia. At the same time, we guarantee the fulfillment of tasks. We return funds for failures that do not depend on our qualifications or capabilities. The situation in the pharmaceutical market is characterized as unstable.
In particular, 4 amendments to the current law and Federal Law No. 429-ФЗ “On Amendments to the Federal Law “On Circulation of Medicines” have already been adopted. Standards and requirements are changing, and we monitor the market constantly, we do not miss even the smallest details.
- Always provide services on contractual terms, and sometimes earlier.
- Prepare weekly reports on the progress of projects
- Payment in stages is provided upon completion of a part of the project.
- There are discounts when entering the market / registering several drugs. They affect the total cost of the client.
- We offer bonuses for repeated orders — focused on the long-term cooperation.