EU & Baltic Regulatory Expertise
Regulatory consulting and market compliance support across the European Union and Baltic States
FMS Baltic provides regulatory consulting services for medicinal products, medical devices, food supplements, nutraceuticals and cosmetics across the European Union, with particular expertise in Latvia, Lithuania and Estonia.
We support manufacturers, marketing authorisation holders, importers, distributors and life sciences organisations in navigating EU legislation and country-specific regulatory requirements.
What We Offer
- Regulatory pathway and product classification assessments
- Country-specific regulatory requirements for Latvia, Lithuania and Estonia
- Marketing authorisation and lifecycle support for medicinal products
- Medical device regulatory compliance under the MDR and IVDR
- Food supplement and nutraceutical compliance assessments
- Cosmetic product regulatory requirements and notifications
- Product information, labelling and language compliance
- Regulatory documentation review and authority correspondence
Medicinal Products
We support pharmaceutical regulatory activities under the applicable EU and national frameworks, including marketing authorisations, variations, renewals, MAH transfers and national product information requirements.
Our services include regulatory documentation coordination and support for interactions with competent authorities.
Medical Devices
We provide regulatory consulting concerning Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
Support may include device classification, conformity assessment pathway evaluation, technical documentation gap assessments, economic operator obligations and post-market regulatory compliance.
Food Supplements and Nutraceuticals
We assist companies in assessing compliance with EU food legislation and national requirements in the Baltic States.
Our support includes ingredient and composition assessments, food supplement notification requirements, labelling, nutrition and health claims, and market-specific restrictions.
Nutraceutical products are assessed according to their legal classification and intended use.
Cosmetics
We support regulatory compliance assessments under Regulation (EC) No 1223/2009, including:
- Product classification and ingredient compliance
- Cosmetic Product Safety Report (CPSR) documentation requirements
- Product Information File (PIF) compliance
- Cosmetic Products Notification Portal (CPNP) requirements
- Responsible Person obligations
- Labelling and claims compliance
Baltic States Regulatory Expertise
Latvia
Regulatory support involving the State Agency of Medicines and other competent authorities responsible for relevant product categories.
Lithuania
Assessment of national regulatory requirements, notification procedures, documentation and product compliance obligations.
Estonia
Support for national regulatory requirements, product documentation, notification obligations and market compliance.
Cross-Border Regulatory Coordination
FMS Baltic assists clients operating across multiple EU markets by identifying differences in national implementation, language requirements, notification procedures and regulatory responsibilities.
Our approach combines EU-level regulatory knowledge with practical country-specific assessments.
Discuss Your EU & Baltic Regulatory Requirements
Contact FMS Baltic to discuss regulatory compliance, product registration, notification or market entry requirements in the European Union and Baltic States.