Our US Services

US Regulatory Strategy

We partner with sponsors from early development to post-approval, providing a US-focused and globally aligned regulatory strategy. Our support is practical and senior-led, helping teams make informed decisions and engage effectively with the FDA. Our strategy support includes:

• FDA regulatory pathway and route-to-market planning
• Preparation for FDA meetings and written interactions
• Gap analysis and regulatory risk assessment
• Support for expedited pathways and special designations

We work closely with your team to interpret FDA feedback and translate it into clear, actionable next steps.

FDA Submissions and Regulatory Operations

DLRC provides end-to-end support for FDA submissions and regulatory operations. We manage the preparation, review and lifecycle management of regulatory dossiers, combining high-quality technical writing with efficient, compliant delivery.

Our operational support includes:

• US Agent responsibilities
• Gap analyses and Target Product Profiles
• Pre-IND, IND, NDA/ANDA and BLA submissions
• Orphan drug designation, expedited pathways, PSPs/waivers
• Technical writing and document review
• Submission planning, coordination and publishing
• Response to FDA questions
• Clinical trial transparency/disclosure services
• CRO oversight

Our focus is on clarity, consistency and quality to support efficient FDA review and minimise avoidable rework.

Pre-IND and Investigational New Drug (IND) Support

DLRC supports sponsors across the full pre-IND and IND pathway in the US, from early regulatory strategy and meeting preparation through to IND submission and subsequent FDA interactions. Support includes defining regulatory expectations, shaping pre IND briefing packages, and advising on the alignment of nonclinical, CMC, and clinical development plans to enable a robust transition into first-in-human and later phase studies. DLRC works closely with sponsors to develop clear, scientifically grounded development rationales and regulatory narratives that reflect FDA guidance and precedents, helping to anticipate and mitigate potential risks to study timelines and outcomes. Experience across multiple therapeutic modalities and disease areas allows for pragmatic, programme specific advice, including coordination with global development strategies where appropriate. For US programmes, this approach supports efficient IND progression, reduces the likelihood of clinical holds, and helps position development plans for downstream regulatory success.

Orphan Drug Designation (ODD)

DLRC supports sponsors through all stages of the Orphan Drug Designation process in the US, from assessing eligibility and developing the justification through preparing FDA submissions and managing follow-up interactions. We help companies present strong prevalence analyses, medical plausibility arguments, and development rationales tailored to FDA expectations. Our expertise extends across both US and EU orphan frameworks, enabling sponsors to leverage global rare disease incentives and coordinate parallel applications where appropriate. For US programmes in particular, we help sponsors maximise the benefits of ODD, including tax credits, fee reductions, and potential market exclusivity, to strengthen the viability of rare disease pipelines.

Expedited Pathways (Fast Track, Breakthrough Designation, Accelerated Approval, Priority Review, RMAT, QIDP)

The DLRC team has a strong track record of supporting expedited program strategies across multiple therapeutic areas and stages of development. Our consultants have extensive experience with FDA interactions and designation requests and work collaboratively with clients to provide the right level of support at the right time. We are committed to delivering high-quality, strategically aligned regulatory documentation that supports efficient development, reduces risk, and accelerates the path to approval and patient access.

NDA (New Drug Application)/ANDA (Abbreviated New Drug Application) Expertise

DLRC provides end-to-end regulatory support for NDA /ANDA submissions, helping sponsors navigate the complexities of FDA review, clinical data requirements, CMC expectations, and labelling negotiations. Our consultants have deep, hands on experience preparing and managing NDAs/ANDAs for programmes entering the US market, ensuring dossiers are strategically positioned for an efficient FDA assessment. With integrated expertise across the US, EU and UK, we support globally coordinated submission planning, bridging differences between FDA and EMA requirements to reduce rework, mitigate regulatory risks, and keep development timelines on track.

BLA (Biologics License Application) Expertise

For biologics and advanced therapies, DLRC delivers specialised support for BLA development, preparation and lifecycle management. Our teams are experienced in addressing FDA expectations around quality, manufacturing control strategies, comparability, and clinical evidence for biologics. We work closely with sponsors to ensure BLAs are scientifically robust, well structured, and aligned with the FDA’s evolving standards for biologics and ATMPs. Our global team also advises on EU biologics submissions (e.g., MAA), allowing sponsors to streamline data packages and harmonise regulatory approaches across regions.