Local regulatory expertise across CEE and Emerging markets. Learn More
- Hrastovec 5, 1236 Trzin, Slovenia
INTERNATIONAL REGULATORY CONSULTANCY
Local Regulatory Expertise. Successful Market Access.
Artemisa provides regulatory support for companies operating across Central and Eastern Europe and emerging neighboring markets. We combine regulatory expertise, local knowledge and practical execution to help our clients navigate complex requirements and bring their products to market with confidence.
WHO WE ARE
About Artemisa
Artemisa is an international regulatory consultancy specialising in plant protection products, biocontrol products, adjuvants, fertilisers and biocides.
Our experienced team members are based across different markets and supported by a trusted network of local regulatory experts. Together, we provide our clients with regulatory knowledge, local insight and practical support needed to successfully manage registrations across multiple countries.
We work as an extension of our clients’ teams, helping them turn complex regulatory requirements into clear and achievable pathways to market.
Our experienced team members are based across different markets and supported by a trusted network of local regulatory experts. Together, we provide our clients with regulatory knowledge, local insight and practical support needed to successfully manage registrations across multiple countries.
We work as an extension of our clients’ teams, helping them turn complex regulatory requirements into clear and achievable pathways to market.
- Business Certificates: Excellent SME Certified
- Coordinated Multi-Country Registration Management
- Seamless Extension of Your Regulatory Team
OUR KEY ADVANTAGES
Why Artemisa?
Regulations may be harmonised across parts of Europe, but successful registrations depend on understanding how they are applied in practice. Every authority has its own expectations, administrative procedures and communication style. Outside the EU, regulatory systems can differ even more significantly.
EXPERT NETWORK
Local Regulatory Experts
Country-specific knowledge and deep understanding of local regulatory frameworks across CEE and emerging markets.
AUTHORITY INSIGHT
Practical Authority Knowledge
Practical understanding of authority expectations, administrative procedures, and document evaluation criteria.
DIRECT DIALOGUE
Native-Language Communication
Direct, effective communication with national competent authorities in their native language.
SINGLE POINT OF CONTACT
One Dedicated Project Manager
Single point of contact for all markets, ensuring clear overview, central tracking, and smooth execution.
SIMULTANEOUS ENTRY
Coordinated Multi-Country Submissions
Synchronised registration strategies across multiple territories reducing time-to-market and administrative costs.
END-TO-END CARE
Strategy Through Post-Authorisation
Comprehensive support from initial dossier preparation and strategy through re-evaluations and post-authorisation activities.
PRODUCT LIFECYCLE SUPPORT
Regulatory Services
We provide regulatory and market access support throughout the product lifecycle across the following areas:
REGULATORY SERVICE
Plant Protection Products
Comprehensive regulatory support for plant protection products across EU and non-EU markets.
REGULATORY SERVICE
Biocontrol Products
Regulatory support for biological and alternative plant protection solutions.
REGULATORY SERVICE
Fertilisers & Biostimulants
Regulatory and market access support for fertilisers, biostimulants and soil improvers.
REGULATORY SERVICE
Labels & Safety Data Sheets
Preparation, review and translation of product labels, Safety Data Sheets and regulatory documentation.
REGULATORY SERVICE
Adjuvants
Country-specific adjuvant requirements, from national registration to authority communication.
REGULATORY SERVICE
Biocides
Support under the EU Biocidal Products Regulation and national frameworks outside the EU.
REGULATORY SERVICE
Strategic Advice
Strategic advice on regulatory pathways, market entry and multi-country registration planning.
TARGET MARKETS
Our Regulatory Coverage
We provide comprehensive regulatory management and local submission support across 28 markets in Europe and neighboring regions:
- EU Countries: Baltics, Bulgaria, Croatia, Czech Republic, Greece, Hungary, Italy, Poland, Romania, Slovakia, Slovenia
- Southeast Europe (SEE) & Türkiye: Albania, Bosnia & Herzegovina, Kosovo, Montenegro, North Macedonia, Serbia, Türkiye
- Emerging markets: Armenia, Azerbaijan, Egypt, Georgia, Moldova, Ukraine, Kazakhstan, Uzbekistan
Our offices
CroatiaHungaryPolandRomaniaSlovakiaSloveniaTürkiyeUkraine
START YOUR REGULATORY JOURNEY
Planning Your Next Market Entry?
Whether you are entering a new market, expanding an existing portfolio or coordinating registrations across several countries, our experts can help you identify the right regulatory pathway and manage the process from strategy to execution.