Although regulatory content often takes centre stage, the process of mapping regulatory operations is frequently viewed as a secondary concern, deferred to a later phase. However, overlooking this step can be the critical factor between meeting a non-negotiable deadline and delivering content that falls short in formatting quality and navigational usability.

This article highlights the pivotal role and systems that a skilled Regulatory Operations function plays during the often time-constrained phases of a project. It highlights the key advantages of having a strong regulatory operations team in place – especially when sponsor experience is limited. Understanding common challenges at this stage can be the deciding factor between success and delay.

• Intelligence: Successfully navigating the ever-familiar challenges specific regulatory landscape – while aligning with a global submission strategy and maintaining compliance – requires deep insight, specialised expertise, and dedicated resources. This need becomes even more critical as we approach the transition to the eCTD v4.0 specification. Robust internal intelligence and surveillance capabilities empower advanced global submission planning. Additionally, active collaboration with software vendors and participation in pilot programs help us manage complexity, build confidence, and ultimately reduce risk.
• Visibility: Compressed timelines can place significant pressure on teams, potentially impacting submission quality. Strategic planning and initiative-taking monitoring are key to delivering high-quality submissions within set deadlines. Assigning a dedicated Submissions Manager and leveraging structured Content Plan templates is highly beneficial, ensuring timelines are clearly defined, realistic, and achievable.
• Transparency: Effective document version control and well-defined processes are critical for identifying the primary source of truth. Allowing multiple versions of documents to circulate across teams and locations can introduce significant errors, unnecessary rework and dramatically increase a review workload.
• Agility: The ability to think critically, respond swiftly, and deliver effective solutions is essential. A skilled Submissions Manager plays a pivotal role in this. At Boyds, we combine strong project management capabilities with advanced technical expertise to ensure quality is never compromised and validation issues are proactively avoided.
• Regional Insight: Tailored regional and individual support enhances efficiency. While eCTD is designed as an electronic Common Technical Document format, regional variations remain in common modules. Proactively identifying, assigning, and addressing region-specific requirements – supported by prior knowledge – allows teams to allocate resources more effectively across other critical areas.
• Systems: Integrating technology – particularly unified submission platforms – accelerates processes while ensuring accuracy, completeness, and consistency across submission content.

At Boyds, our deep expertise drives consistent success – powered by seamless cross-functional collaboration, proven processes, and a commitment to data integrity.

Get in touch to speak to a member of our Regulatory Operations team to find out how we can help you to navigate the submissions process.