Regulatory-Aligned HTA & Market Access Support

DLRC is a trusted HTA, access and regulatory partner with a global foot print. From pre-clinical to post-launch, our UK, US, and EU teams partner with biotech, pharma, advanced therapy and medtech companies to accelerate access and maximise value.

The measurable impact of strategic HTA & access support

Maximised evidence ROI

Every research investment should drive reimbursement success. We help you prioritise the most effective evidence generation that delivers optimal coverage decisions and pricing. No wasted research, no missed opportunities, just strategic evidence investment that maximises your return.

Accelerated time-to-reimbursement

Speed to market means competitive advantage. Our proactive HTA planning starts early, making sure your evidence generation aligns with payer expectations from Phase II onward. While competitors struggle to meet HTA requirements post-approval, you’re already positioned for fast-track reimbursement.

Data transformed into value stories

Clinical data alone doesn’t win coverage – compelling value stories do. We identify evidence gaps before they become roadblocks, design studies that meet HTA requirements, and craft submissions that resonate with decision-makers. Your breakthrough science becomes breakthrough market access.

HTA & Access services that drive results

We can provide end-to-end support for your HTA journey, including:

HTA Strategy & Planning

We develop comprehensive HTA roadmaps that align evidence generation with regulatory timelines and commercial objectives. By conducting early assessment of HTA requirements across target markets, we identify evidence gaps and create solutions to pave the path for optimal evaluation. Our planning ensures the clinical development program generates the right evidence for a promising evaluation decision.

Evidence Generation Consulting

We design and execute evidence strategies that meet HTA body expectations and support value propositions. We guide health economics research through therapy cost estimation and budget impact to payers. Our team helps prioritise studies that deliver maximum impact for coverage and pricing negotiations.

HTA Submission Preparation

We craft compelling submissions that clearly communicate clinical and economic value to decision-makers. We prepare comprehensive dossiers for NICE, ICER, CADTH, G-BA, and other HTA bodies, making sure submissions are complete, scientifically rigorous, and strategically structured. Our experience with reviewer expectations helps avoid common mistakes and delays.

Stakeholder Engagement & Advisory

We facilitate productive dialogue with HTA bodies, payers, clinical experts, and patient advocacy groups throughout the review process. We coordinate advisory boards, manage scientific consultations, and prepare you for committee presentations. Our established relationships help navigate complex stakeholder dynamics and proactively address their concerns.

Market Access Intelligence

We provide strategic and targeted access support to ensure optimal pricing and reimbursement have been achieved. Our experience with pricing helps design the best contracting strategy. We monitor policy changes, track the competitive landscape, and analyse trends to inform your strategy.

Ready to align your regulatory strategy with market access success?

Book a discovery call to find out how our HTA experts can help accelerate your market access journey.

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Beyond traditional HTA services

Most HTA consultants focus on one side of the coin, either regulatory or commercial. DLRC delivers both, making sure every decision supports approval and commercial success.

The DLRC Difference: Regulatory & Commercial Alignment

Integrated teams

Our regulatory and commercial experts work together on every engagement.

Dual success metrics

We don’t just promise ‘better HTA advice’. We track approval rates and reimbursement outcomes to ensure your investment delivers maximum value.

Cross-functional deliverables

Every recommendation includes regulatory impact AND revenue implications. This strategic integration positions us as your strategic partners, not just tactical executors.

Find out more about DLRC

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Testimonials

See what our clients have to say about DLRC

Thank you so much for your support and for guiding us through the entire process! Especially the last couple of weeks were so intense and have shown how important a well aligned team is! Great job everyone … You were our compass all the time… you were always spot on when needed; and all the time, you gave us the confidence to get where we wanted to be at the end.

We wanted to extend our thanks for all of your hard work, expertise and thoughtful partnership … You have been instrumental in operationalizing … capabilities we have been building together across people, process, tech, and content. We know that it hasn’t been easy at times because we are building something totally new and consider you a great partner to navigate this with. We are really looking forward to our continued work … Thank you!”

I take this opportunity to thank you for your initiative and agility in leading regulatory response and strategy in unexpected circumstances … Your support is indispensable and highly appreciated.

I would like to thank DLRC for the great leadership of the filing team and the fantastic preparation and chairing of the pre-submission meeting with the team and rapporteurs. It is great to have your experience and expertise on board for this important filing. The team managed to get all possible information from the rapporteurs in a fruitful and professional atmosphere, fostering great communication amongst the attendees.

We’d like to acknowledge DLRC for their hard work and ‘whatever it takes’ mindset during the recent project activities they completed for us, including key protocol amendment submissions made across multiple countries.

As a small biotech company with no facilities in Europe, we needed a strong partner to represent us and to support our global initiatives. The team assigned to our program has provided a broad range of regulatory expertise and operational support, and has been thorough, organized, responsive, and a pleasure to work with. The onboarding of the DLRC team was seamless, and they made efforts to familiarize themselves with our product and program right away so that they could contribute to both strategic planning and execution. I look forward to continuing our partnership as we progress our program.

Regulatory Aligned HTA & Market Access Support