Regulatory intelligence, legislative monitoring and market compliance across multiple life sciences product categories
FMS Baltic provides regulatory intelligence and market compliance consulting for medicinal products, medical devices, food supplements, nutraceuticals and cosmetics.
We help manufacturers, marketing authorisation holders, distributors and life sciences organisations understand evolving regulatory requirements, identify compliance risks and evaluate the implications of regulatory changes for their products and business activities.
What We Offer
- Research and interpretation of legislation, regulatory guidance and competent authority requirements
- Monitoring of regulatory developments and changes affecting specific product categories
- Country-specific regulatory requirements and compliance assessments
- Product classification and regulatory pathway analysis
- Identification of compliance gaps, regulatory risks and implementation requirements
- Comparative regulatory assessments across selected markets
- Targeted regulatory intelligence reports and practical recommendations
Regulatory Intelligence and Legislative Monitoring
We monitor and assess developments in EU, national and regional regulatory frameworks, including new legislation, amended requirements, regulatory guidance and implementation deadlines.
Our support includes evaluating how these developments affect product classification, regulatory obligations, documentation, labelling, safety requirements and continued market availability.
Product-Specific Regulatory Compliance
Medicinal Products
Regulatory intelligence covering pharmaceutical legislation, marketing authorisation requirements, lifecycle obligations and regulatory authority guidance.
Medical Devices
Assessment of EU MDR/IVDR requirements, device classification, conformity assessment pathways, post-market surveillance obligations and applicable regulatory guidance.
Food Supplements and Nutraceuticals
Assessment of food legislation, ingredient restrictions, permitted health and nutrition claims, labelling requirements and national notification obligations where applicable. Nutraceuticals are assessed according to their actual legal classification rather than treated as a separate harmonised EU regulatory category.
Cosmetics
Assessment of EU Cosmetics Regulation requirements, product classification, ingredient restrictions, safety assessment obligations, labelling and product notification requirements.
Market Compliance Assessments
FMS Baltic evaluates the regulatory conditions affecting the placement and continued availability of products in selected markets.
Our assessments may cover:
- Applicable regulatory classification and legal framework
- Market-specific documentation and notification requirements
- Labelling, language and product information obligations
- Regulatory responsibilities of manufacturers, importers and distributors
- Identification of compliance deficiencies and recommended corrective actions
Comparative Regulatory Research
We support clients operating across multiple jurisdictions by comparing regulatory requirements and identifying relevant differences between markets.
Assignments may include targeted country assessments, comparative regulatory studies, regulatory feasibility evaluations and analysis of emerging regulatory developments.
Flexible Regulatory Intelligence Support
FMS Baltic provides project-based regulatory research, defined compliance assessments and specialist regulatory intelligence support.
Projects can range from a single product classification question to a comprehensive multi-country regulatory requirements assessment.
Discuss Your Regulatory Intelligence Requirements
Contact FMS Baltic to discuss your regulatory research, legislative monitoring or market compliance assessment needs.