Access and Cost Benefits for SMEs
We understand the unique challenges faced by Small and Medium-sized Enterprises (SMEs) in the pharmaceutical and biotech industries. That’s why we are proud to offer significant access and cost benefits through our qualification as an SME in the European Union (EU).
Our services
What can we do for you?
By partnering with us, you can make the most of our SME qualification to enhance your regulatory strategy and reduce costs indirectly through strategic planning and access to available incentives. Let us help you navigate the complexities of regulatory requirements and take advantage of the support benefits available to SMEs.
Contact us to learn more about how our SME status can benefit your business and to discuss your regulatory needs. Together, we can achieve compliance and drive forward progress in healthcare innovation.
Our SME status allows us to benefit from the specialized support and guidance from the European Medicines Agency (EMA). This includes tailored scientific advice and protocol assistance, which helps optimize your regulatory strategy and ensure compliance with EU requirements.
Our SME qualification enables us to leverage various financial incentives and support mechanisms available to small and medium-sized enterprises, facilitating submissions and interactions with the EMA on your behalf while maximizing these benefits.
Our SME qualification enables us to facilitate more efficient and streamlined regulatory processes. This means we can help you reduce the time, resources and costs needed for your submissions, potentially speeding up your path to market access.
Benefit from our agile and flexible approach to regulatory consultancy. We can quickly adapt to your needs and provide personalized services that align with your business objectives, helping you navigate the complexities of regulatory requirements effectively.
Utilize our expertise to navigate the regulatory landscape with a strategic approach. We provide insights and advice on leveraging the SME benefits to enhance your overall regulatory strategy and achieve your goals more efficiently.
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
Questions from our clients
FAQ Section
Our qualification as a Small and Medium-sized Enterprise (SME) in the EU allows us to provide enhanced guidance and access to specialized support from the European Medicines Agency (EMA). We can help you leverage various financial incentives and support mechanisms available to SMEs. This includes accessing tailored scientific advice and protocol assistance from the EMA, which can optimize your regulatory strategy and streamline the submission process. Additionally, our SME status allows us to facilitate more efficient regulatory procedures, potentially reducing the time and resources needed for your submissions and accelerating your path to market access.
he EMA provides a range of financial incentives and support mechanisms specifically for SMEs, including:
- Fee Reductions: Significant discounts on various regulatory fees.
- Fee Waivers: Exemptions from fees for specific activities.
- Deferral of Fees: Deferred payment options to ease cash flow pressures.
- Scientific Advice and Protocol Assistance: Reduced fees for crucial regulatory guidance.
- SME Office Support: Dedicated support and guidance tailored to SMEs.
- Market Exclusivity Incentives: Market exclusivity and additional support for orphan drugs.
- Assistance with Translations: Free translations of required documentation for market authorization.
These incentives are designed to support SMEs in the development, authorization, and marketing of their medicinal products, ultimately facilitating innovation and improving public health.