Navigate Complexity with Confidence
Bringing a new medicine to market in Europe requires navigating a fragmented regulatory and reimbursement environment. At Kintiga, we provide strategic advisory services that address the unique challenges of market access across the cross the European Union (EU), the United Kingdom (UK) and the European Economic Area (EEA).
Whether you are launching a first-in-class therapy, managing a multi-indication product, or adapting to evolving policy landscapes, our experts work as an extension of your team. We integrate market access, pricing & reimbursement, regulatory, clinical, HEOR, and commercial perspectives into one cohesive strategy—starting early in development and continuing through post-launch optimisation.
Unlock market success with strategic precision
We know what it takes to succeed in Europe’s complex healthcare markets. With unmatched expertise in access and payer pathways, we’re here to guide you every step of the way.
Understanding Europe’s diverse and evolving markets is challenging, for established organisations and new entrants. We assess market potential with strategic due diligence to provide a detailed evaluation of the local competitive and regulatory landscape, assessing treatment paradigms, pricing structures, and stakeholder perceptions. This forms the foundation for crafting strategies tailored to your product’s unique positioning and market potential. This includes:
- Integrated market access strategy across major and emerging EU markets
- Launch sequencing, lifecycle access planning, and indication sequencing
- Cross-functional alignment to support internal and external stakeholder engagement and insights gathering
- Customer engagement strategy and support
- Integrated evidence strategy, value proposition, product positioning, and value articulation
- Complex therapies, such as gene therapies and ATMPs, and CMC expertise
Achieving reimbursement at optimal pricing levels is challenging, especially when balancing payer expectations, local market nuances, and commercial objectives. At Kintiga, we develop robust pricing and reimbursement strategies tailored to the distinct differences of each market while harmonising them with your broader global goals. By crafting robust, tailored pricing and reimbursement strategies, value dossiers, and HTA submissions, we help you proactively align with payer needs and secure optimal pricing.
We are your partner for:
- Pricing research and modelling, market landscaping and cost-effectiveness assessments
- Launch sequencing through international reference pricing
- Stakeholder insight gathering and Payer research
- Performance-based reimbursement models, risk-sharing or cap models
- Contract negotiations with regional health insurers across Europe
- Comprehensive payer negotiation support
Reaching the right stakeholders at the right time is critical to success. Our team identifies key decision-makers—whether they’re payers, physicians or patient advocacy groups—to build lasting relationships that drive impactful outcomes. From bespoke advisory boards to tailored stakeholder management plans, we connect you with those who matter most.
We support building and maintaining relationships with external stakeholders with:
- Advisory boards, Delphi panels and expert elicitation research
- Scientific stakeholder management, including Medical Science Liaison (MSL) coordination
- Medical Affairs Plans (MAP), Expert Engagement Plans (EEP), Medical Education and CME
- Medical and scientific communications including Medical Information and Publication Planning & Execution
- KOL and stakeholder management
Every market is different, every product unique, and every ambition distinct. We work as an extension of your team to develop strategies specifically for you—addressing your challenges, aligning with your ambitions and positioning you for success in Europe’s diverse healthcare markets and beyond. Misaligned messaging or inconsistent evidence can undermine even the best therapies. We know how vital it is to create a clear, compelling narrative that reflects your innovation’s full value. By combining insights from market access, HEOR, strategic pricing, policy and public affairs, we ensure your asset’s value is captured in a cohesive, persuasive dossier.
We support with:
- Evidence generation including systematic literature reviews and HEOR analyses
- Payer and stakeholder engagement and insights
- PIM and EAMS applications
- Global value dossier (GVD) development
- Optimum evidence package from launch sequencing to international reference pricing
Change is constant, and staying ahead can be complex amid time constraints and increasing competitive pressures. That’s why we proactively track regulatory and policy updates, payer expectations, and market trends to ensure your strategy stays on course. Backed by deep expertise and a continuously growing understanding of Europe’s healthcare systems, we provide the timely insights and adjustments needed to keep you ahead of the curve—helping you seize opportunities and navigate challenges with confidence.
- Ongoing reports on market access, HTA and stakeholder development
- Tailored analysis and bespoke materials on policy and legislative changes
- HTA Tracker
- Policy Tracker
Evidence gaps can obstruct the path to patient access, leading to unnecessary delays that could have been prevented. By integrating early health economic modelling into your development process, we help you define the evidence required to support pricing and reimbursement objectives. This proactive approach aligns your product’s clinical value with market expectations, clearing the way to successful commercialisation. At Kintiga, we help you create robust evidence that resonates with stakeholders.
We support with:
- Health economic and budget impact modelling (BIM), from early analysis and model review to full model development.
- Evidence generation and gap analysis
- Payer landscape insights
- Custom models and insights for local market local markets
- Treatment pathway and model input validation
- HTA modelling
Early missteps can lead to costly delays and unnecessary challenges, making early engagement essential to building a strong, successful market access strategy. At Kintiga, we work alongside your development teams from the early phases, aligning development with your ambitions from the start—enabling smarter decisions, reducing risks, and laying the groundwork for seamless entry into diverse markets.
- Early development and strategic planning for optimal access results
- Landscape analysis and go-to-market commercial planning
- Clinical trial assessment and gaps analysis
- Early economic modelling and Target Product Profile testing
- Facilitate early engagement and dialogue with regulators, HTA bodies, and clinicians to confirm strategy and product positioning
Confronted with complex pathways and differing local requirements? Kintiga simplifies regulatory processes with tailored strategies, timely approvals, and seamless navigation of regulatory requirements, saving you time and avoiding delays.
- Expert Strategic regulatory advice including EMA Scientific Advice, EMA Prime, ODD, scientific advice, ILAP (Innovative Licensing and Access Pathway), and paediatric investigation plans (PIPs).
- EU Orphan Drug designation
- Marketing authorisation applications (Centralised, mutual recognition, decentralised, and national procedures).
- Lifecycle management
- CMC expertise
- Medical device certification
- Digital health market entry – DiGA expertise in Germany
Feel confident that patient safety and compliance are in expert hands. With comprehensive services, we ensure effective adverse event management and deliver accurate, accessible medical information to stakeholders.
Our Pharmacovigilance (PV) and medical information services include:
- ICSR management
- Local and global literature screening
- 24/7 Local Contact Person PV, QPPV services and global PV setup
- Development and execution of risk management plans and activities (RMP & RMA)
- Audit & Inspection readiness
- 24/7 local and global medical information support
