Supporting your regulatory activities via Boyds’ EMA SME status
Boyds holds official Small and Medium-sized Enterprise (SME) status with the European Medicines Agency (EMA), allowing us to extend key regulatory and financial benefits to qualifying clients
What does EMA SME status mean?
The European Medicines Agency (EMA) awards SME status to companies that meet the EU’s definition of a small or medium-sized enterprise. This designation enables access to specific regulatory, procedural, and financial support designed to help innovative smaller companies bring new therapies to market.
Boyds holds official EMA SME status and can act on behalf of clients as their registered SME representative. This enables companies – particularly those not established in the European Economic Area (EEA) – to access these important incentives through collaboration with Boyds.
Filing in the UK and Europe can be complex, especially as regulatory frameworks evolve post-Brexit.
We help you navigate MHRA and EMA requirements, ensuring your submissions are well-prepared, compliant, and strategically aligned for approval.
How Boyds’ SME Status Benefits You
Boyds holds registered SME status to support micro, small, and medium-sized enterprises operating in the pharmaceutical sector that are seeking regulatory guidance and marketing authorization for medicinal products within the European Union (EU).
SMEs in this sector are typically innovative companies that can benefit from access to scientific expertise at EU level. Through the EMA SME initiative, eligible companies can receive up to a 90% fee reduction for scientific advice, encouraging engagement with the EMA on all matters related to product development. This support helps maximize the chances of success during marketing authorization.
By working through Boyds’ SME registration, qualifying companies can access the EMA’s full range of SME incentives, even if they are not directly established within the European Economic Area (EEA).
By working with Boyds to obtain SME status in the EU, SMEs can benefit from a range of incentives, including:
- Direct support from the EMA SME Office, including dedicated briefings and procedural guidance
- Fee reductions or exemptions for scientific advice, inspections, post-authorization activities, and certain administrative services
- Deferred or conditional fee waivers for marketing authorization applications where EMA advice is followed
- Certification of quality and non-clinical data for advanced therapy medicinal products (ATMPs)
- Free product-information translations for marketing authorization submissions
- MedDRA licensing fee waiver for micro or small enterprises registering with EudraVigilance
- Inclusion in the EMA SME public register
Additional benefits for qualifying products include:
Full EMA fee waiver for scientific advice on orphan drug and PRIME scheme applications
Up to 90% fee reductions for GMP, GCP, GLP, and pharmacovigilance inspections, with the option to defer pre-authorization inspection fees
These incentives are designed to lower barriers to regulatory engagement, accelerate development timelines, and improve access to regulatory expertise.
End-to-End Regulatory Support Through SME Status
Boyds combines the advantages of EMA SME status with decades of experience in regulatory strategy and product development.
Our consultants support clients at every stage of interaction with the EMA, from early scientific advice and protocol assistance through to marketing authorization applications (MAA) and post-approval activities.
By partnering with Boyds, you gain a trusted representative who can help you engage directly with regulators, reduce procedural costs, and accelerate time to market.
Learn more about how Boyds supports clients throughout the UK, Europe, and globally:
Regulatory Affairs Services
Back to Regulatory Affairs
Looking to file in the US?
Expertise with FDA IND, NDA & BLA submissions
Find out moreLooking to file in the UK or Europe?
Specialist support for EMA, MHRA & national submissions
Find out moreTake Advantage of EMA SME Benefits Through Boyds.
Speak to our award-winning regulatory team to explore whether your company qualifies and how we can support your next submission.
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.