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!

500+
our client base is 500+ companies and influencers
6000+
consultations
200+
product registrations and certifications in various categories
5000+
documents
About Us

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.

Medical Device Registration

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:

01
Analysis and Registration Roadmap Evaluation
— Device Classification: Determine the medical device type and risk class
— 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
02
Preparation of Application Dossier
— Compile Instructions for Use (IFU), technical files, normative documents, risk management files, and adapt reports as needed
03
Production QMS Site Inspection (parallel for the above)
— Prepare for inspection of production sites, whether on-site or online
04
Submission and Follow-Up
— Filing: Submit all necessary documentation to Roszdravnadzor
— Inquiries: Respond promptly to formal and essential inquiries regarding dossier completeness and data integrity
05
Final Approval
— Obtain the Marketing Authorization (MA) document
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.
Contact Us Today!
Medicinal Products Registration

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

Apply form
Dietary Supplements, FSMPs & Cosmetics Registration and Certification

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:

 

01
Active components:

—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)
02
Excipients and auxiliary components:
Need to be indicated by weight for capsules, tablets, powders; for liquid forms by mass per 100 ml or %, to be indicated by name, index E, purpose of the component in the product.

— 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.
03
The single dose and daily dose of the dietary supplement should be indicated.

— (Example: 1 capsule 3 times a day. 1 measuring cup (10 ml) twice a day), as well as desired age indications with dosing.
04
The single dose and daily dose of the dietary supplement should be indicated. (Example: 1 capsule 3 times a day. 1 measuring cup (10 ml) twice a day).
Upload
Portfolio and Business Development
Custom Formulation Services for Dietary Supplements and Cosmetics
More details
Authorized Representation and Trade Services for Foreign Medical Device Manufacturers in Russia and EAEU
More details
Comprehensive Product Portfolio Development Services
More details
Marketplace Access and Registration Services for Wildberries and Ozon
More details
Why Work With Us
Expertise and Experience:
Expertise and Experience: Our employees have held managerial positions in international pharmaceutical companies across Russia, the US, and Europe, spanning marketing, sales, business development, and government relations. We possess a deep understanding of the business environment, opportunities, limitations, requirements, and risks.
Comprehensive Information:
Comprehensive Information: We work with a vast array of databases and sources, both local and global, which are continuously updated. Our information resources include industry professionals, service providers, healthcare officials, patient associations, and top-level managers within companies.
High-Quality Services:
High-Quality Services: Our reports and services meet international standards in both content and format, ensuring you receive top-quality support.
Professional Network:
Professional Network: Our multilingual staff and extensive network allow for wide-ranging research. We have established relationships with key decision-makers, key opinion leaders in medical and regulatory fields, and can easily conduct market research, polls, and surveys to support your strategic or tactical business decisions. markets. Additionally, we offer a comprehensive range of business development services for companies already established in these regions.