Specialist EU Representation for Global Life-Science Firms
EMA SME Annexing & Orphan Drug Sponsorship
Unlock immediate access to European Medicines Agency fee savings without the complexity. Annex your company to our pre-approved EMA SME status for fee reductions on scientific advice, inspections, and procedures. Plus, get professional orphan drug designation sponsorship to accelerate rare disease development.
We provide focused fee-saving services that integrate seamlessly with your existing regulatory setup—whether in-house teams, established CROs, or external consultancies.
Our Core Services
EMA SME Status Annexing
What We Do
Annex your company to Pharma Gateway's existing EMA-approved SME profile for immediate benefits
Handle all SME registration paperwork, renewals, and compliance maintenance
Provide ongoing support for SME-related EMA interactions and communications
Your Benefit
Immediate eligibility for fee reductions or full waivers on scientific advice, inspections, and post-authorization procedures
Fast-track access, typically 2-4 weeks, depending on the complexity of the application and the speed of the EMA SME office
Independent of your existing regulatory setup, you use your own account to communicate with EMA
Orphan Drug Designation Sponsorship
What We Do
Serve as your EEA-based sponsor for orphan designation applications on the EMA IRIS platform
Coordinate post-designation compliance including submitting annual reports
Handle regulatory communications while your team maintains scientific and development control
Your Benefit
Access to protocol assistance, priority evaluation, and 10-year market exclusivity
Additional fee reductions and regulatory incentives for rare disease development
Maintain full scientific ownership while meeting EU sponsorship requirements
How We Fit into Your Strategy
Not a full-service consultancy
We remove only the EU-establishment hurdle and secure cost-saving incentives. Your existing regulatory experts stay in the driver's seat.
Plug-and-play collaboration
We provide the mandatory legal representation, handle EMA communications for SME and ODD matters, and leave the scientific, CMC, and clinical content to your preferred advisors.
Partner network on tap
Need EU regulatory bandwidth? We can introduce specialist consultancies we trust—no referral fees, just the right fit for your programme.
Why Choose Pharma Gateway?
Laser-focused expertise
All we do is EU legal representation for SME status and orphan sponsorship—you won't pay for services you don't need.
Speed to savings
Annexing to our existing SME account means fee reductions can start with your very first EMA interaction.
Transparent, fixed pricing
Flat-fee packages with no surprise "consultancy" hours.
Frequently Asked Questions
SME annexing allows your company access to apply for SME status and receive fee reductions without having to be established in the EU. We handle all paperwork and ongoing compliance while you get instant benefits.
EMA SME (Small and Medium-sized Enterprise) status provides fee reductions or complete waivers on scientific advice, inspections, protocol assistance, and many post-authorization procedures. Savings can range from thousands to hundreds of thousands of euros depending on your regulatory activities.
Orphan drug designation (ODD) sponsorship means we act as your EEA-based sponsor on the EMA IRIS platform for rare disease treatments. This provides access to protocol assistance, priority evaluation, 10-year market exclusivity, and additional fee incentives while you maintain scientific control.
No. We work alongside your existing regulatory team, CRO, or consultancy. We only provide the EU legal representation and handle SME/ODD administrative matters, while your chosen experts continue managing the scientific, CMC, and clinical content.
If you annex to our existing SME account, fee reductions can begin with your very first EMA interaction. The annexing process typically takes 2-4 weeks, depending on the complexity of the application and the speed of the EMA SME office.
Companies qualify for SME status if they have fewer than 250 employees, annual turnover not exceeding €50 million or balance sheet total not exceeding €43 million, and are independent (not more than 25% owned by larger enterprises). We help you access these benefits through our annexing service.
We handle all SME registration paperwork, annual renewals, compliance maintenance, and serve as your point of contact with EMA for SME-related matters. You get immediate access to our existing SME status without the wait time of creating your own.
Yes, we maintain a trusted network of regulatory consultancies. We can introduce you to the right partner for your specific therapeutic area and development stage—with no referral fees, just the right fit.
SME fee reductions apply to scientific advice, protocol assistance, inspections, marketing authorization applications, variations, annual fees, and many post-authorization procedures. Orphan designations also qualify for additional incentives and fee waivers.
We offer transparent, flat-fee packages with no surprise consultancy hours. Pricing depends on the specific services required (SME annexing, ODD sponsorship, or administrative services) and the scope of your regulatory activities. Contact us for a personalized quote.
No, by design. We focus exclusively on SME annexing and orphan drug sponsorship services. This allows us to be cost-effective and work seamlessly with your existing regulatory experts who handle the scientific and technical aspects.
SME annexing gives you immediate access to EMA fee reductions for general pharmaceutical procedures. Orphan drug sponsorship is specifically for rare disease treatments, providing additional benefits like market exclusivity and priority evaluation. Many companies use both services for maximum savings and regulatory advantages.
Open Your Gateway to Europe
Let Pharma Gateway provide the legal foothold you need, while your scientific team—or trusted regulatory partner—focuses on bringing breakthrough therapies to European patients.
