DLRC 2025: A Year of Impact and Innovation

In 2025, DLRC marked a transformative year defined by strategic growth, regulatory excellence, and a deepened commitment to sustainability and innovation. Despite a challenging year globally, DLRC has continued to welcome new clients and to support valued existing ones. Highlights from the year include achieving prestigious certifications, launching new services, as well as celebrating two decades of impact.

A Foundation of Excellence: Certifications That Matter

DLRC’s pursuit of excellence was formally recognised in February 2025, when the company achieved ISO 9001:2015 certification for its Quality Management Systems. This internationally recognised standard, awarded by BSI, validates DLRC’s commitment to process optimisation, customer-focused solutions, and continuous improvement.

“Achieving ISO 9001:2015 certification reflects our unwavering commitment to regulatory excellence,” said CEO Dianne Lee. “Our team has worked hard to implement a Quality Management System that enhances our processes and procedures to ensure we consistently exceed customer expectations.”

This milestone not only reinforces DLRC’s reputation as a trusted regulatory partner but also strengthens its operational framework, ensuring clients receive consistent, high-quality service across all engagements.

In April 2025, DLRC further demonstrated its dedication to client data security by achieving Cyber Essentials Plus certification, the highest level of cybersecurity accreditation under the UK’s National Cyber Security Centre (NCSC) scheme.

“This significant milestone underscores our unwavering commitment to maintaining the highest standards of security,” said Drew Williams, Head of IT & Systems. “It’s a testament to the hard work and diligence of the entire DLRC technical team.”

We are also delighted to highlight that our CEO, Dianne Lee, achieved Chartered Director Status this year. Chartered Director status is an exclusive qualification held by some of the world’s best business directors and leaders. This award is not only an achievement but also highlights Dianne’s drive and ambition to build a better board at DLRC and a stronger business.

Officially a Certified B Corporation

In November 2025, DLRC became a Certified B Corporation (B Corp), demonstrating that we meet high standards across our entire operation, including governance, workers, environment, customers and community. We were shown to be accountable, transparent and to have goals that go beyond shareholder value. This is a huge achievement for which every member of our team should be proud.

Industry Recognition

In November this year, DLRC was proud to be recognised across multiple categories at the prestigious TOPRA Awards, which celebrate excellence in regulatory affairs. A highlight was Thea Morgan, Senior Regulatory Associate, winning the Rising Star Award, reflecting her rapid progression and leadership potential. Thea’s journey from intern to Senior Regulatory Associate in under three years exemplifies DLRC’s commitment to developing talent and fostering regulatory excellence. Our AI team was also shortlisted for the Innovation Award after they developed a tool for redacting confidential information from clinical documentation showcasing DLRC’s dedication to forward-thinking solutions.

Empowering Innovation: New Services for a Changing Landscape

DLRC’s strategic expansion in 2025 included the launch of two major service offerings designed to meet evolving client needs.

Regulatory Catalyst: Supporting Startups with Clarity and Confidence

In April, DLRC introduced the Regulatory Catalyst, a transparent, fixed-price package tailored for startups navigating complex regulatory pathways. The Catalyst includes:

• Scope: Regulatory orientation session
• Strategy: Personalised path-to-market workshop
• Structure: Complete regulatory roadmap report
• Showcase: Investor-ready pitch deck

This offering empowers emerging biotech and medtech companies to accelerate market entry while avoiding common pitfalls. With access to DLRC’s senior experts and over 1,000 years of combined regulatory experience, startups gain clarity, confidence, and compliance from day one.

HTA & Market Access Support: Bridging Regulatory and Commercial Success

In August 2025, DLRC also launched its Regulatory-Aligned HTA & Market Access Support service. This strategic offering helps innovators navigate EU health technology assessment (HTA) requirements, unlock reimbursement potential, and accelerate patient access.

Key features include:

• HTA strategy and planning
• Evidence generation consulting
• Submission preparation
• Stakeholder engagement
• Market access intelligence

DLRC’s integrated approach ensures that clinical development aligns with payer expectations, transforming breakthrough science into compelling value stories.

Celebrating 20 Years of Excellence

July 2025 marked DLRC’s 20th anniversary, a moment to reflect on two decades of growth, innovation, and global impact. Founded in 2005, DLRC has evolved from a small UK-based consultancy into an international organisation with offices in the UK, EU, and the US.

With a multidisciplinary team of over 80 experts and experience across more than 50 therapeutic areas, DLRC has supported hundreds of clients in navigating the complex global healthcare landscape.

DLRC’s journey has been punctuated by prestigious awards, including its third King’s Award for Excellence in International Trade, and its continued commitment to employee development, client satisfaction, and regulatory innovation.

Sustainability and ESG: A Responsible Future

In 2025 DLRC has continued our journey towards Net-Zero and our commitment to our community. This year we have:

• Become a B Corp!
• Started to calculate our scope 3 emissions
• Partnered with PlanetMark
• SBTi approved
• Worked with Landlords to move to a renewable electricity supplier
• Set several targets on waste, recycling, and water usage
• Started to incorporate our European and US companies into our sustainability practices as part of the One-DLRC policy
• Raised £2656 for the Teenage Cancer Trust, purchased 15,024 Creme Eggs for the Garden House Hospices’ Charlie Chicks Campaign and separately raised over £800 for GHH. We have also raised money for other charities including the Linda Norgrove Foundation, Jeans for Genes and the Samaritans.

Being a sustainable business is something increasingly recognised and expected by our clients. We are looking forward to publishing our 2025 Sustainable Impact Report at the beginning of next year and look forward to taking on further challenges in the area of sustainability to further our journey.

People First: Growth, Wellbeing, and Leadership

DLRC’s success is rooted in its people. In 2025, the company welcomed new team members and celebrated internal promotions that reflect its commitment to career progression. Leadership changes also shaped the year, with James Biddlecombe and Wafa Bouaziz stepping into new roles as Chief Operating Officer (COO) and Chief Regulatory Officer (CRO), respectively. Their strategic vision and global expertise will guide DLRC’s continued expansion across the UK, EU, and US. This enhancement to the executive team will accelerate DLRC’s impact, not just in the industry but for the patients who rely on us.

Employee wellbeing remains a top priority. In 2025 DLRC:

• Held 13 Health and Wellbeing talks, on topics including post-partum psychosis, epilepsy, and dementia
• Partnered with Fertility Network UK who provided a health talk and have helped to establish our new Fertility Ambassadors
• Trained a further three Mental Health First Aiders

Global Presence: Events That Matter

Throughout 2025, DLRC demonstrated its commitment to thought leadership and global industry engagement by actively participating in a wide array of high-profile events across the life sciences and regulatory landscape. These included conferences such as BIO JPM Week, BIOCEO 2025, and both the Spring and Autumn editions of BIO Europe, as well as specialised conferences like Advanced Therapies Europe and presentations at the LSX World Congress in both the UK and the USA. DLRC’s presence at Cambridge Wide Open Week, BIO International 2025, and the TOPRA Symposium further underscored our dedication to staying at the forefront of regulatory innovation. Participation in BIOSPAIN, NLS Days, RESI London & Boston, and DDL provided valuable opportunities for DLRC experts to share insights, foster strategic partnerships, and remain agile in response to evolving global regulatory trends.

In addition to these in-person events, DLRC held hundreds of virtual meetings with clients worldwide, ensuring that geographical limitations never hinder collaboration. This approach highlights our commitment to accessibility and flexibility, offering tailored solutions to advance products for potential clients. By combining face-to-face interactions with robust digital connectivity, DLRC continues to deliver expertise and support wherever our clients are located.

Strategic Partnerships

Our strategic partnerships further amplify this commitment. As proud members of organisations such as One Nucleus, OBN, Conexen, and the BioIndustry Association (BIA), DLRC actively participates in numerous events hosted by these organisations throughout the year. These collaborations provide invaluable opportunities to engage with industry leaders, share regulatory insights, and contribute to shaping the future of life sciences. Our continued membership reflects DLRC’s dedication to supporting the wider ecosystem through meaningful connections and knowledge exchange.

We also deepened our global footprint through new strategic partnerships with leading innovation hubs this year. Collaborations with the BIG incubator and Hong Kong Science and Technology Parks (HKSTP) have enabled DLRC to support emerging biotech and medtech companies in Asia with tailored regulatory guidance. With an Affiliate Membership Program with Babraham Research Campus, DLRC would further strengthen support for early-stage startups in the UK & Europe.

Looking Ahead: Innovation and Impact

DLRC’s accomplishments in 2025 reflect a forward-thinking organisation that is not only meeting the evolving demands of the life sciences sector but actively shaping the future of regulatory affairs. With a strategic focus on harnessing artificial intelligence and automation to streamline regulatory processes, DLRC is driving greater efficiency and precision across its services. The company’s ongoing B-Corp evaluation also signals a deep commitment to responsible governance, sustainability, and ethical business practices. Additionally, DLRC continues to cultivate strategic partnerships across the biotech and medtech sectors, reinforcing its role as a trusted collaborator in advancing innovation. These initiatives position DLRC to further its mission of improving global healthcare outcomes through regulatory excellence and impactful industry leadership.

One Team, One Vision

DLRC’s 2025 was a year of purpose, progress, and powerful transformation. From certifications and service launches to sustainability and also team growth, every milestone reflects a unified vision: to deliver world-class regulatory support that empowers clients, uplifts communities, and drives innovation.

As the regulatory landscape evolves, DLRC remains a trusted partner, ready to guide clients through complexity with clarity, confidence, and care.

To conclude, our CEO, Dianne Lee (FTOPRA, FIoD, CDir), shares her reflections on an exceptional year:

”2025 has been an incredible year and we have achieved so much. I recognise the efforts of the whole team and there have been some outstanding contributions from individuals. The energy in the room is here and I am looking forward to an exciting 2026!”