SME Status & Exploitant Services
Empowering Market Access through our SME status and Exploitant Capabilities
At AzurBio, we offer targeted regulatory support through our recognized SME status with the European Medicines Agency (EMA) and our dedicated Exploitant services via AzurBio Pharma. These specialized capabilities allow us to facilitate your development and commercialization strategy in the EU-cost-effectively and compliantly.
Whether you’re a biotech start-up, a non-EU company entering the European market, or an established firm seeking local representation, we provide the structure and expertise to support your growth.
Our Expertise
Our SME & Exploitant Services Includes:
Regulatory Support via EMA SME Status
As a company with recognized SME status at the EMA, AzurBio can help eligible clients access a range of valuable regulatory incentives.
Our services include:
As a company with recognized SME status at the EMA, AzurBio can help eligible clients access a range of valuable regulatory incentives.
Our services include:
- Acting as your SME representative to extend eligibility to non-EU or start-up sponsors
- Securing fee reductions or exemptions for scientific advice, inspections, and marketing authorization procedures
- Navigating simplified processes for early dialogue with EMA committees
- Facilitating direct access to EMA’s SME Office, supporting strategy development and regulatory alignment
We leverage our status to accelerate your development and reduce your regulatory costs-particularly critical in early-phase and resource-constrained environments.
Exploitant Services via AzurBio Pharma (France)
Through our affiliate AzurBio Pharma, we provide full Exploitant services to ensure your products meet the specific legal and regulatory requirements for commercialization in France.
This includes:
- Serving as the Exploitant for pharmaceutical products on the French market
- Managing regulatory responsibilities such as marketing authorization oversight, compliance with ANSM (Agence nationale de sécurité du médicament), and product traceability
- Ensuring quality obligations and pharmacovigilance compliance at the national level
- Acting as the local “person responsible”, as required by French regulation
This service is essential for companies without a French affiliate, enabling you to maintain a compliant and operational presence in one of Europe’s key pharmaceutical markets.