Services Regulatory Submissions Management
At DLRC, our Regulatory Operations team bring over 75 years of combined experience in managing regulatory submissions across global regions. We offer a comprehensive, end-to-end service tailored to your needs. From strategic submission planning to electronic Common Technical Document (eCTD) compilation, our team ensures that every submission meets the highest quality and compliance standards .
With a global presence and offices in the UK, EU, and US, DLRC accelerates submission efficiency by leveraging an extended workday. Our team has grown significantly, helping clients successfully navigate the complexities of regulatory submissions.
25 Major submissions delivered from mid-2020 to the end of 2024:
Take a look at how we have helped our clients.
A medium-sized pharmaceutical client approached DLRC seeking assistance with submission planning for a complex New Drug Application (NDA). The client required experienced resources with advanced publishing expertise to manage this significant regulatory milestone. The project presented considerable challenges, including coordinating 120 different studies within a single application. The comprehensive submission ultimately totalled over one million pages of documentation, requiring meticulous organisation and validation.
DLRC responded by appointing a dedicated Regulatory Operations lead who oversaw a specialised publishing team. This expert group provided strategic oversight, leveraged global publishing capabilities, and focused on milestone delivery throughout the project lifecycle. The team implemented a shared regional content plan that gave all stakeholders real-time visibility of the project status. This approach significantly enhanced transparency and collaboration across all teams involved in the submission.
Through careful planning and expert execution, our Regulatory Operations Team successfully submitted a fully validated NDA to the FDA. The submission was completed a day ahead of schedule, demonstrating DLRC’s ability to handle complex regulatory submissions efficiently whilst maintaining the highest quality standards.
A small life sciences company approached DLRC with no prior experience or infrastructure in Regulatory Operations. They faced the daunting task of navigating their first Investigational New Drug (IND) filing without an Electronic Document Management System (eDMS) or publishing software. The client’s limited knowledge of the regulatory framework presented a significant hurdle to achieving a successful submission.
DLRC provided comprehensive support to bridge these capability gaps. From the outset, we delivered practical advice on planning, scheduling and regional requirements tailored to the client’s needs. Our team deployed advanced Adobe tools to ensure efficient compliance updates and added essential navigational aids throughout the documentation. We implemented a robust Submission Content Plan that kept the project on track, complemented by a thorough Quality Control (QC) review process that identified and resolved potential issues before submission.
With DLRC’s guidance and support, the client submitted their IND application on time. Despite the client’s initial lack of regulatory infrastructure, the submission met the highest quality and validation standards. This success established a strong foundation for the client’s future regulatory activities and demonstrated DLRC’s ability to effectively support organisations at any stage of regulatory maturity.
A commercial-stage biopharmaceutical company partnered with DLRC for regulatory guidance and publishing support for their FDA New Drug Application (NDA). The submission presented several significant hurdles. The team needed to manage an enormous dataset exceeding 1,000,000 pages while ensuring accurate content placement within the submission. The legacy reports also required updating to meet current technical standards. Despite lengthy processing times, frequent draft outputs were essential to stay within strict regulatory timelines for team review.
DLRC’s Regulatory Operations team implemented a strategic workflow to overcome these challenges. They established automated software runs during off-hours to generate outputs without disrupting daytime operations. The team maintained continuous dialogue between client, regulatory experts, and operations teams throughout the process. This approach leveraged the advantage of having Regulatory and Regulatory Operations teams in the same country. By utilising mirrored time zones, they maximised productivity and responsiveness at every stage.
This approach delivered exceptional outcomes for the client. The team completed the submission one day ahead of schedule with no technical issues during the submission process. Regulators had minimal validation questions, and the application ultimately achieved successful approval.
When the global pandemic took hold in 2020, our client, a biotech company specialising in bioactives, identified a promising molecule under investigation that could potentially benefit patients infected with COVID-19. As the situation was rapidly evolving, time was critical to ensure suitable therapies were made available as quickly as possible. The client approached DLRC to support with the expedited addition of COVID-19 as an indication to their existing Investigational New Drug (IND) application.
The Regulatory Operations team collaborated closely with the client to prepare and submit the IND update to the FDA. Working with exceptional urgency, the team completed and submitted the application within just one week of receiving the initial request.
Through this rapid response, DLRC successfully accelerated the preparation and submission process. This swift action enabled the potential benefits of the molecule in treating patients with COVID-19 to be explored without delay, contributing to the urgent global effort to develop effective treatments during the pandemic.
See what our clients have to say about DLRC
