Regulatory approval consulting services
Navigating complex and fragmented country regulations
Expanding into the European market presents significant regulatory complexity. Whilst the European Medicines Agency provides centralised approval, each of the 27 EU member states maintains its own pricing, reimbursement and regulatory frameworks. Navigating diverse healthcare systems and varying national guidelines creates substantial barriers to market entry and delays patient access to innovative treatments.
Sciensus’ regulatory approval consulting removes these barriers with tailored strategic guidance throughout the European regulatory journey. With 30 years of experience, we develop optimal pathways for market authorisation, manage country-specific submissions and accelerate time to market. Our end-to-end approach ensures you can focus on innovation whilst we handle the regulatory complexity.
Faster route to market
Reduced regulatory risk
Comprehensive market coverage
Strategic regulatory guidance from EMA approval to product availability
Sciensus activates your centralised EMA approval with individual country market access. Our regulatory experts develop tailored strategies for each member state, manage all submission requirements and coordinate with national competent authorities across Europe. From early access programmes that build real-world evidence to full marketing authorisation and commercialisation, we provide the regulatory expertise and local knowledge needed to navigate Europe’s complex pharmaceutical landscape successfully.
Do you want to know more about navigating European regulatory approval?
Partner with Sciensus to streamline your path to market across Europe. Our regulatory experts will develop a tailored strategy that reduces risk, accelerates approvals and ensures compliance. Get in touch to discuss your regulatory needs.
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Product registration and submissions
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Regulatory compliance management
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Strategic market access planning
30 years of European regulatory expertise
End-to-end regulatory solution
Tailored, plug-and-play approach
Frequently asked questions
What is the difference between EMA approval and country-level market access?
The European Medicines Agency provides centralised approval for medications across the EU, resulting in a single marketing authorisation. However, each of the 27 member states maintains its own pricing, reimbursement and regulatory frameworks. This means EMA approval is just the first step – individual negotiations and submissions are required in each country to achieve full market access.
How long does the European regulatory approval process typically take?
The timeline varies depending on the therapy area, regulatory pathway and number of markets targeted. EMA centralised approval typically takes 12-18 months, whilst individual country pricing and reimbursement negotiations can add significant time. Our strategic approach and established relationships with national competent authorities help streamline this process and reduce delays.
What are expanded access or compassionate use programmes?
Expanded access programmes (also called compassionate use programmes) allow patients to access treatments before full marketing authorisation is granted. Eighteen EU countries have developed national guidance around these programmes. They’re valuable for gathering real-world data, building relationships with clinicians and supporting future regulatory submissions whilst providing early patient access.
Does Sciensus support regulatory approval for all therapy areas?
Yes, our regulatory consulting services are therapy agnostic. Whilst we have extensive experience in rare and orphan disease markets, our expertise spans all therapeutic areas. We tailor our regulatory strategies to meet the specific requirements of your product and target markets across Europe.
What regulatory responsibilities do Sciensus manage as part of the service?
We handle the full spectrum of regulatory requirements including marketing authorisation applications, pharmacovigilance, adverse event reporting, quality person release, medical information management, promotional materials approval and ongoing compliance with national competent authorities. Our comprehensive approach ensures all MAH responsibilities are met across every market.
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Get in touch
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