DLRC Regulatory Consultancy

DLRC Regulatory Consultancy is a UK-based regulatory affairs consultancy established in 2005, serving pharmaceutical, biotech, and medical device companies worldwide. The firm employs over 80 regulatory professionals with backgrounds from pharmaceutical companies and regulatory agencies, providing services to more than 130 clients ranging from Top 5 pharmaceutical companies to small and medium enterprises.

The consultancy offers comprehensive regulatory support across the product lifecycle, including early development scientific advice, clinical trial regulation, marketing authorisation applications, and post-licensing activities. Their service portfolio encompasses medicines and medical devices regulation, medical and scientific writing, HTA and market access support, submissions management, and representative services. DLRC operates as a Certified B Corporation and maintains ISO 9001 accreditation.

The firm has received multiple industry recognitions, including two King's/Queen's Awards for Enterprise in International Trade (2017, 2021, 2024) and three TOPRA Awards for Regulatory Excellence. DLRC has also earned Investors in People Silver accreditation twice and has been recognized for workplace wellbeing and people development initiatives.

Organizations should consider DLRC when they need regulatory expertise that bridges agency and industry perspectives, particularly for complex European regulatory pathways or multi-market strategies. The consultancy's flexible engagement models accommodate both single-issue projects and long-term strategic partnerships.

Companies can expect a collaborative approach with emphasis on pragmatic solutions, as evidenced by client testimonials highlighting responsive communication, strategic guidance, and operational support. The B Corporation certification and ISO 9001 accreditation indicate commitment to structured processes alongside flexible service delivery.

DLRC operates exclusively in the pharmaceutical and medical device regulatory space, concentrating on product development, clinical trials, marketing authorisations, and post-market surveillance. The consultancy's healthcare focus encompasses medicines across all therapeutic areas and medical devices from development through quality management, serving the life sciences sector specifically rather than broader healthcare services or IT.

Their expertise includes navigating European clinical trial regulations, FDA pathways, and global regulatory harmonization requirements. The firm also provides specialized HTA and market access support aligned with regulatory strategies, recognizing the increasing intersection of regulatory approval and reimbursement pathways in healthcare markets.

The ideal client is a pharmaceutical, biotech, or medical device company requiring regulatory strategy and operational support for European or global market access. This includes startups building initial regulatory frameworks, mid-sized companies managing clinical trial submissions, and established organizations optimizing lifecycle management. Companies valuing collaborative partnerships and flexible engagement structures will find the consultancy's approach particularly suitable.