Regulatory strategy, product registration and compliance across international markets
FMS Baltic provides regulatory affairs consulting for medicinal products, medical devices, food supplements, nutraceuticals and cosmetics across the EU, Baltic States, CIS/EAEU and Central Asia.
We support manufacturers, marketing authorisation holders, distributors and life sciences organisations throughout the regulatory lifecycle, from product classification and market entry to registration and ongoing compliance.
Our Regulatory Services
Medicinal Products
- Marketing authorisation applications and CTD/eCTD dossiers
- Variations, renewals and MAH transfers
- Regulatory documentation, labelling and authority correspondence
Medical Devices
- MDR/IVDR classification and regulatory pathway assessments
- Technical documentation and conformity assessment support
- Registration, post-market surveillance and compliance
Food Supplements & Nutraceuticals
- Product classification, ingredient and composition assessments
- National registration and notification requirements
- Labelling, nutrition and health claims compliance
Cosmetics
- Ingredient compliance and product safety documentation
- PIF, CPSR and CPNP requirements
- Labelling, notification and market compliance
International Regulatory Support
We provide country-specific regulatory assessments, documentation reviews and coordination of regulatory activities across European and selected international markets.
Flexible Consulting
Our services are available for individual regulatory questions, defined projects and ongoing regulatory support, including specialist subcontracting.
Discuss Your Regulatory Requirements
Contact FMS Baltic to discuss your product registration, regulatory compliance or market entry needs.