FMS Baltic Ltd is an independent pharmaceutical and life sciences consulting company established in Latvia in 2006.
We provide specialised regulatory affairs, pharmacovigilance, regulatory intelligence and clinical development support to pharmaceutical, biotechnology and healthcare companies.
Our experience covers the European Union, the Baltic States, Eastern Europe, CIS/EAEU countries and Central Asia.
FMS Baltic combines scientific expertise, practical regulatory experience and knowledge of national regulatory environments to help clients navigate complex requirements, develop regulatory strategies and bring healthcare products to international markets.
We work with pharmaceutical manufacturers, biotechnology companies, contract research organisations and international regulatory consulting partners, offering flexible, project-based support tailored to individual client needs.
Our Experience & Expertise
Established in 2006, FMS Baltic provides specialised regulatory and scientific consulting services across multiple healthcare and life sciences product categories.
Our expertise encompasses:
- Pharmaceuticals: Marketing authorisations, regulatory submissions, lifecycle management, regulatory intelligence, pharmacovigilance and compliance.
- Medical Devices: EU MDR regulatory requirements, product classification, conformity assessment pathways, technical documentation and regulatory support for international markets.
- Food Supplements: Product classification, ingredient compliance, labelling, notification and registration requirements, and market entry assessments.
- Cosmetics: EU Cosmetics Regulation compliance, product classification, labelling requirements, safety documentation and regulatory procedures for non-EU markets.
- Clinical Development: Clinical trial regulatory submissions, CTIS procedures, GCP compliance, clinical monitoring and ethics committee support.
- International Regulatory Intelligence: Regulatory strategy, gap assessments and country-specific regulatory requirements across the EU, Eastern Europe, CIS/EAEU and Central Asia.
We support manufacturers, marketing authorisation holders, distributors and international consulting partners with practical, science-based regulatory solutions tailored to their products and target markets.