Drug Licensing & Reimbursement
We are experts in navigating your drugs and devices through the regulatory process. Here at R-S-S we bring together years of first-hand experience from those working in major health regulatory agencies (e.g. FDA, EMA, MHRA) to help solve the unique and complex challenges and requirements clients face throughout the clinical development process.
Regulatory Expertise
At R-S-S, we offer end-to-end support to help you successfully bring your pharmaceutical and medical device products to market, ensuring regulatory compliance and optimal access to healthcare systems worldwide. By understanding evolving regulations and payer requirements, we streamline your product’s market entry and accelerate reimbursement decisions, maximising both commercial potential and patient access to innovative therapies and technologies.
Our Services
- Regulatory Dossier Management
- Clinical Trial Execution
- Health Economics & Outcomes Research
- Scientific Advice Support
- Real-World Evidence Generation
- Payer Engagement & Market Access
- Quality & Risk Management
Regulatory Dossier Management
Regulatory dossier preparation and submission management to ensure compliance with FDA, EMA, and other global authority requirements.
Clinical Trial Execution
Clinical trial design, management, and execution to generate robust efficacy and safety data to support licensing applications.
Health Economics & Outcomes Research
Health economics and outcomes research (HEOR) solutions to develop value dossiers and economic models that demonstrate cost-effectiveness for reimbursement negotiations.
Scientific Advice Support
Support for scientific advice meetings with regulatory and HTA bodies to align development plans with market expectations.
Real-World Evidence Generation
Real-world evidence generation and post-marketing surveillance to support ongoing reimbursement and market access.
Payer Engagement & Market Access
Coordination of payer engagement strategies and market access planning to optimize coverage and pricing outcomes.
Quality & Risk Management
Quality assurance and risk management throughout the drug/device lifecycle, ensuring regulatory adherence and smooth approval processes.
Regulatory Dossier Management
Regulatory Dossier Management
Regulatory dossier preparation and submission management to ensure compliance with FDA, EMA, and other global authority requirements.
Clinical Trial Execution
Clinical Trial Execution
Clinical trial design, management, and execution to generate robust efficacy and safety data to support licensing applications.
Health Economics & Outcomes Research
Health Economics & Outcomes Research
Health economics and outcomes research (HEOR) solutions to develop value dossiers and economic models that demonstrate cost-effectiveness for reimbursement negotiations.
Scientific Advice Support
Scientific Advice Support
Support for scientific advice meetings with regulatory and HTA bodies to align development plans with market expectations.
Real-World Evidence Generation
Real-World Evidence Generation
Real-world evidence generation and post-marketing surveillance to support ongoing reimbursement and market access.
Payer Engagement & Market Access
Payer Engagement & Market Access
Coordination of payer engagement strategies and market access planning to optimize coverage and pricing outcomes.
Quality & Risk Management
Quality & Risk Management
Quality assurance and risk management throughout the drug/device lifecycle, ensuring regulatory adherence and smooth approval processes.
Why Partner With Us?
- Leverage our deep expertise to efficiently navigate complex drug and device licensing regulations, reducing risk and accelerating approvals.
- We offer tailored strategies for diverse global markets, aligning submissions with evolving regulatory and payer requirements.
- We provide end-to-end support from dossier preparation to regulatory engagement and post-approval compliance, ensuring seamless market entry.
- Our teams develop strong health economic and value dossiers to support reimbursement decisions and maximise commercial potential.
- Our teams facilitate effective communication and negotiation with regulatory bodies and payers to streamline licensing and reimbursement pathways.
- We mitigate financial and operational risks through proactive planning and thorough understanding of intellectual property and licensing terms.
Our approach ensures your innovative therapies and technologies reach patients quickly and efficiently across global healthcare systems.
- Leverage our deep expertise to efficiently navigate complex drug and device licensing regulations, reducing risk and accelerating approvals.
- We offer tailored strategies for diverse global markets, aligning submissions with evolving regulatory and payer requirements.
- We provide end-to-end support from dossier preparation to regulatory engagement and post-approval compliance, ensuring seamless market entry.
- Our teams develop strong health economic and value dossiers to support reimbursement decisions and maximise commercial potential.
- Our teams facilitate effective communication and negotiation with regulatory bodies and payers to streamline licensing and reimbursement pathways.
- We mitigate financial and operational risks through proactive planning and thorough understanding of intellectual property and licensing terms.
Our approach ensures your innovative therapies and technologies reach patients quickly and efficiently across global healthcare systems.
Partner with us to reduce uncertainty, mitigate risks, and achieve reimbursement success across global markets.
Global Regulatory and Market Access Support
Scientific Advice for Drug Licensing and Reimbursement
We offer expert support and scientific advice throughout the drug licensing and reimbursement journey, helping you engage effectively with regulatory authorities and HTA bodies. With robust scientific advice, we help reduce regulatory uncertainty, enhance the quality of your submission dossiers, and accelerate approval timelines.
New Drug Applications and Submissions
Navigating the complex process of New Drug Applications (NDAs) is made easier with our expertise. We provide strategic advice and hands-on support in compiling and submitting NDAs, ensuring that all regulatory requirements are met to achieve timely approval and market entry.
Joint Clinical Assessment (JCA)
At R-S-S, we support your engagement with the European Union’s Joint Clinical Assessment (JCA) process by offering comprehensive expertise navigating its rigorous and collaborative framework. The JCA is a centralised evaluation conducted under the EU HTA Regulation, providing scientific assessments of the relative clinical effectiveness and safety of new health technologies across member states.
Our team can assist you in preparing and submitting robust JCA dossiers by aligning evidence generation with the PICOS framework (Population, Intervention, Comparison, Outcome, Study design) essential for scoping and assessment. We help interpret and incorporate the JCA outputs to optimise market access strategies, ensuring your products are positioned effectively within diverse EU healthcare systems. Our support mitigates complexity by managing timelines, stakeholder consultations, and regulatory requirements, accelerating adoption and reimbursement decisions across Europe.
Experience in Middle East, Africa and Asia-Pacific Markets
The landscape of market access in the Middle East, Africa and Asia-Pacific is undergoing a significant transformation. At R-S-S, our specialised market access consulting services empower our clients to develop effective strategies for market entry, engage with payers, and communicate value across the Middle East, Africa and Asia-Pacific.
Each country in Asia has its own unique regulatory framework. Our experts also have experience in dealing with these markets, working with regulatory bodies like National Medical Products Administration (NMPA), Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Food and Drug Safety of the Republic of Korea (MFDS).