Regulatory affairs and product compliance support across CIS and Eurasian Economic Union markets
FMS Baltic provides regulatory consulting services for medicinal products, medical devices, food supplements, nutraceuticals and cosmetics across CIS and Eurasian Economic Union (EAEU) markets.
We support manufacturers, marketing authorisation holders, importers, distributors and life sciences organisations navigating regional regulatory frameworks and country-specific requirements.
Our experience includes pharmaceutical registration, product classification, regulatory documentation, market entry assessments and regulatory lifecycle management.
What We Offer
- Regulatory pathway and product classification assessments
- Country-specific registration and market entry requirements
- Preparation, review and coordination of regulatory documentation
- EAEU and national registration procedure support
- Regulatory gap assessments and compliance reviews
- Variations, renewals and post-registration regulatory activities
- Labelling, product information and language requirements
- Regulatory authority correspondence and deficiency response support
Medicinal Products
We support pharmaceutical registration and lifecycle activities under applicable EAEU and national regulatory frameworks.
Our services include:
- Evaluation of EAEU and national registration pathways
- Regulatory dossier preparation and gap assessments
- Support for registration, renewal and variation procedures
- Coordination of responses to regulatory authority questions
- Assessment of country-specific regulatory obligations
Medical Devices
We provide regulatory support for medical devices under applicable EAEU and national requirements.
Activities may include device classification, registration pathway assessments, documentation reviews, conformity assessment requirements and post-registration regulatory obligations.
The applicable procedure is assessed according to the product, target country and regulatory provisions in force.
Food Supplements and Nutraceuticals
FMS Baltic assists with regulatory assessments for food supplements and nutraceutical products, including:
- Product classification and applicable regulatory framework
- Ingredient and composition compliance
- State registration or other applicable market access procedures
- Product documentation and safety evidence requirements
- Labelling and claims compliance
Nutraceutical products are assessed according to their legal classification in each target market.
Cosmetics
We support cosmetic product regulatory assessments covering applicable EAEU technical regulations and national requirements.
Our services may include product classification, ingredient compliance, conformity assessment or state registration requirements, labelling and documentation review.
EAEU Regulatory Framework
The Eurasian Economic Union comprises Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.
Regulatory requirements differ by product category. EAEU harmonised rules, national procedures and transitional provisions must be assessed separately.
FMS Baltic helps clients identify the applicable regulatory pathway and documentation requirements for their products.
Country-Specific Regulatory Support
We provide targeted regulatory assessments for EAEU member states and other CIS markets, taking account of national procedures, competent authority requirements and applicable regulatory differences.
Flexible Regional Regulatory Support
FMS Baltic provides project-based consulting, regulatory documentation reviews, registration support and specialist subcontracting for defined regulatory activities.
Assignments may involve individual product assessments, country-specific regulatory questions or coordination of multi-country projects.
Discuss Your CIS / EAEU Regulatory Requirements
Contact FMS Baltic to discuss product registration, regulatory compliance or market entry requirements in CIS and EAEU markets.