End-to-End Regulatory Support for First-in-Human Studies

A biopharmaceutical client developing a novel small molecule required comprehensive regulatory expertise to progress their asset into First-in-Human (FIH) clinical studies. As an emerging organisation, the client lacked an established in-house regulatory infrastructure, creating a critical need for experienced strategic and operational support to guide development and ensure successful regulatory interactions across regions.

The client’s primary objective was to accelerate early clinical development while ensuring robust regulatory compliance across both the United States and the European Union. This required not only high-quality regulatory documentation but also a coherent global strategy to align submission timelines, manage agency expectations, optimise dossier content and ultimately achieve global regulatory alignment.

Key challenges included:

• Navigating complex regulatory requirements across multiple regions (FDA and EU/CTIS frameworks)
• Developing high-quality, submission-ready documentation for early-phase clinical development in a short period of time. This included IB, IMPD authoring as well as the full pre-IND and IND
• Coordinating cross-functional inputs to support strategic decisions and regulatory interactions
• Establishing efficient processes between the different functions within the clients organisation, external consultants used by the client and the DLRC team

To overcome these challenges and enable efficient progression into clinical trials, the client partnered with DLRC for end-to-end regulatory support.

DLRC acted as an extension of the client’s organisation, effectively serving as an in-house regulatory function. A fully integrated team was deployed to deliver strategic, operational, and medical writing support across all stages of early clinical development.

Key activities included:

• Regulatory Strategy Development and Execution: DLRC designed and implemented a global regulatory strategy, providing expert guidance on submission sequencing across the US and EU. This included optimising dossier content and regulatory positioning to maximise the likelihood of successful outcomes while minimising delays.
• Medical Writing and Core Document Authoring: DLRC led the development of critical regulatory documents, including the Investigator’s Brochure (IB) and Investigational Medicinal Product Dossier (IMPD), ensuring alignment with regulatory expectations and scientific integrity.
• Pre-IND and IND Leadership (US): DLRC managed all aspects of US regulatory engagement, including:
  • Coordinating cross-functional teams to define key questions for regulatory interaction
  • Authoring the pre-IND briefing package
  • Leading preparation and eCTD submission of the IND
  • Developing and coordinating responses to FDA information requests and feedback
  • Acting as the US Agent to facilitate communication with the FDA
• European CTA and CTIS Management: DLRC oversaw the end-to-end Clinical Trials Information System (CTIS) submission process, supporting European Clinical Trial Applications (CTA). This included managing submission timelines and ensuring compliance with evolving EU regulatory frameworks.
• Regulatory Interaction and Response Management: DLRC provided strategic oversight and led the preparation of responses to regulatory queries from EU authorities, ensuring clear, consistent, and scientifically robust communication.
• Ongoing Regulatory Lifecycle Support: DLRC continued to support clinical trial maintenance activities across both US and EU regions, including:
  • Managing study amendments
  • Supporting regulatory submissions for ongoing trials
  • Ensuring continued compliance with regional requirements
• Phase 2 Preparedness and Strategic Planning: As the programme progressed, DLRC supported forward-looking regulatory planning, including preparation for Type C meeting requests and paediatric investigation plan (PIP) activities, ensuring regulatory readiness for the next stage of development.

DLRC successfully enabled the client to progress their novel small molecule into First-in-Human clinical studies, delivering a fully coordinated regulatory strategy and high-quality submission package across both the US and EU regions.

Key outcomes included:

• Successful preparation and submission of IND and CTA applications across regions
• Effective navigation of regulatory interactions, including timely and robust responses to agency queries
• Establishment of streamlined processes for ongoing clinical trial maintenance and regulatory compliance
• Strong alignment between cross-functional teams, supporting efficient decision-making and execution

Beyond initial clinical entry, DLRC’s continued involvement is currently supporting the client’s transition into Phase 2 readiness, ensuring that regulatory strategy remained aligned with long-term development goals.

The collaborative partnership and consistent delivery of high-quality support resulted in strong client satisfaction, leading to the extension of DLRC’s involvement to additional assets and indications. This ongoing relationship reflects the value of DLRC’s integrated approach and its ability to scale alongside client needs.