Experts in market access EAEU markets: registration and certification of products, partnering and distribution
We are international consultancy, striving to become a global leader in providing information services, analytical support, strategic consulting and turnkey solutions for international companies looking to discover and realize new opportunities on existing and potential markets. Trust Intelliris to navigate regulatory EAEU market complexities and get the best of innovative products worldwide for your portfolio!
The name Intelliris is derived from a combination of two Latin roots: «intel» (intelligent) and «iris» (eye, pupil). This embodies our core philosophy — to provide an intelligent, farsighted view that empowers our clients in the healthcare industry. Our knowledge, experience, expert assessment, and insights are designed to enhance your decision-making process.
Since 2014, we have been providing services to clients related to pharmaceutical market access activities in EAEU markets ( Russia, Armenia, Kazakhstan, Kyrgyzstan and Belorussia).
Our Mission
At Intelliris, we are dedicated to providing top-tier information services, analytical support, strategic consulting, and turnkey solutions for businesses. Our goal is to help pharmaceutical and medical companies uncover and seize new opportunities in both existing and emerging markets.
Our Clients
We serve pharmaceutical, para-pharmaceutical, biotech, and medical companies that are either currently operating in or planning to enter the Russian and CIS.
Ensuring your medical device is registered in the Russian Federation is crucial for legal import, use, sale, and production. Our expert services streamline this process, helping you navigate complex regulations efficiently.
Under paragraph 4 of Article 38 of the Federal Law «On the Basis of Health Protection of Citizens in the Russian Federation» (N 323-FZ), registration is mandatory. The Federal Service for Supervision of Healthcare of the Russian Federation (Roszdravnadzor) oversees this registration process. Don’t let regulatory challenges slow down your market entry. Reach out to our team of experts to get started on your medical device registration in the Russian Federation.
Our comprehensive registration process consists of the following milestones:
— Market Research: Identify registered analogues within the EAEU
— Documentation Review: Verify production sites and existing documentation (QMS, ISO, etc.)
— Study Evaluation: Assess the need for technical, toxicological, metrological, and clinical studies
— Inquiries: Respond promptly to formal and essential inquiries regarding dossier completeness and data integrity
Note: If clinical trials involving humans are required, formal permission from the Ethical Committee is necessary
Registration timelines are 9-12 months for national procedure and 15-20 months for EAEU procedure ( Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan). The costы for registering one medical device ranges from $20,000 to $50,000 USD, not including inspection by RZN
Don’t let regulatory challenges slow down your market entry. Reach out to our team of experts to get started on your medical device registration in the Russian Federation.
The drug registration procedure for drugs is divided into 3 stages.
Legislatively, the registration period is defined as follows:
With a complete set of documents — 160 working days, not including preclinical period, clinical trials, time for remedial actions and inspection of the production site
Stage I: GMP inspection ( if needed ) and preparation of dossier in Russian language and submission to the National Center of Pharmaceutical Products Expertise (FGU).
Stage II: • FGU reviews the submitted dossier content to assure the Quality, Safety, and Efficacy of the pharmaceutical product and to check the conformance to the standards laid out by the Roszdravnadzor.
Stage III: • In this stage the expert review is completed and the documents are forwarded to the main office of Roszdravnadzor to issue the regulatory decision.
For generic drug products there is no need to carry out clinical trials, rather bioequivalence studies only, not necessarily in Russia. For new drugs there is need to carry out the clinical trials particularly in the Russian population
Legislatively, the registration period is defined as follows:
With a complete set of documents — 160 working days, not including preclinical period, clinical trials, time for remedial actions and inspection of the production site
To get a preliminary quote for drug registration fill in this Application Form
The first step to successfully launch a dietary supplement in the Russian market is Registration Feasibility Assessment based on the composition of dietary supplement or cosmetic product.
We offer verification of the composition for compliance with the Technical Regulations of the Customs Union 021/2011, 022/2011, 029/2012; Unified Sanitary and Epidemiological and hygienic requirements for products (goods) subject to sanitary and epidemiological supervision (supervision) on a “fee for service” basis.
You can contact us to evaluate possibility for your product to get registration in EAEU markets and upload your composition based on the requirements below:
—Mineral substances need to be indicated in the form of salts (salt name necessarily) with mandatory indication of the mass quantity of the salt and the mass quantity of the mineral
— Vitamins should be indicated in per cent (the content of vitamins is not always 100 %.)
— Raw materials derived from plants ( dried or extracts ) : please indicate the name of the plant, extracts need to be called in Latin name of the plant, if it is extract or powder, which part of the plant, by what biologically active substance the product is standardized, what is the content of the raw material and % of active substance by weight of the raw material itself and % of the active component in it)
— For colouring agents: indicate the composition of the colouring agent
— For flavours: indicate the composition of the flavour. If natural flavor, specify natural
— For hard gelatine capsules, specify what they are made of. If there is a colouring agent, specify the name of the colouring agent and the weight of the colouring agent.
— For soft gelatin capsules indicate the full composition with the weight of the capsule composition.
— (Example: 1 capsule 3 times a day. 1 measuring cup (10 ml) twice a day), as well as desired age indications with dosing.
