The essential combination of generative AI and human expertise in regulatory medical writing

As generative AI reshapes document development across the industry, the question isn’t whether to use it, but how to use it effectively in the regulatory writing services we offer. At Bioscript Group, we are choosing to integrate these tools strategically, partnering the insights brought by expert writers with the benefits of AI.

Generative AI has been reshaping document development across the industry since 2023. Now, just 2 years later, not only have the tools evolved to the degree that adopting AI has become a reality, but it is now a strategic priority for the pharmaceutical industry and service providers alike. More recently, the introduction of agentic AI has realised the benefits of autonomous and intelligent decision making and has reduced further the need for manual intervention. That’s why we’ve integrated a solution with an agentic AI foundation, tailored specifically to regulatory writing.

Unlike prompt-based systems, the agentic AI platform we use operates autonomously, learning, reasoning and generating outputs tailored to the different regulatory documents. This allows our teams to work faster and more efficiently, while maintaining the accuracy and structure critical for submission-ready content.

The value of AI must be embraced, as the investment is more than offset by the benefits it can bring.
AI can support by:
● Accelerating the drafting process, helping teams to meet the goal of accelerated submission, move faster without compromising rigour
● Improving document quality through the application of robust structure and consistency of language and tone
Our platform’s ability to generate high-quality outputs tailored to specific document types, reduces the amount of writer input needed and streamlines the drafting and development process. Shorter development timelines result in faster approvals from regulatory authorities and a reduced time-to-market for new therapies.
While reduced costs, competitive advantage and quicker ROI are clear wins for pharma, the biggest benefit lies for patients. For patients with rare diseases and limited existing treatment options in particular, this could mean access to effective treatments earlier than they would otherwise.

The benefits of generative AI applications in our industry have been discussed, dissected, challenged and celebrated at length. As AI is adopted in the regulatory world, a question remains: where do regulatory writers fit in this new and fast-developing world?

At Bioscript Group, we see AI as a powerful enabler — one that complements the expertise of our people but does not replace it. Whilst AI can currently be used to streamline preparation of high-quality first drafts, assist with review comment resolution, and modernise the regulatory document development process, the value of regulatory writers remains high, particularly in areas where human insight and judgement remain essential.

Regulatory writers retain the upper hand when it comes to applying judgment. They navigate the grey areas — assessing the clinical relevance of findings, identifying potential ethical concerns and understanding how the nuance of language could be interpreted by regulators. Where AI is certainly valuable in expediting the creation of high-quality documents, compliance is not just about following a checklist. It’s about understanding context, anticipating reviewer expectations and ensuring scientific arguments are communicated clearly and convincingly. That’s where our writers add significant value, bringing a level of insight and contextual understanding that is beyond the limit of AI capabilities.

Of course, regulatory writers don’t just write. Our writers are often the ones keeping complex projects on track, aligning timelines flexibly and effectively, and ensuring multiple stakeholder priorities are met. They coordinate appropriate resource allocation with competing priorities, identify potential risks and develop mitigation strategies to address them.

Every document and submission involves input from a multidisciplinary team. Our writers act as the conductor of this orchestra, triaging and resolving comments from multiple reviewers, aligning conflicting views to craft a final document that is scientifically robust and meets the needs of the regulatory authorities.

Balancing differing opinions and navigating team dynamics is key. Experienced writers must be adept at handling the complexities of team politics, facilitating open communication and collaboration across teams that are often large and global. The ability to be mindful of different cultures and working styles is, therefore, vital.

Finally, not all scientific contributors will be aware of the regulatory requirements of every document. Skilled writers must educate, train and support our clients and team members to maintain document and process compliance. They are recognised as trusted experts, standing shoulder-to-shoulder with scientific and clinical leads.

Our experienced writers are responsible for training the next generation of regulatory writers — not just in the fundamentals of writing, but in how to integrate this advanced technology into their workflows. This means we can continue delivering high-quality work as the role that AI plays in this process continues to evolve. 

Generative AI is a powerful tool that, when used in conjunction with the expertise of regulatory writers, can significantly enhance the quality and efficiency of clinical regulatory documents and submissions. Where will the future take us? Nobody knows with 100% certainty, but the skills of the regulatory writer remain essential, and the additive benefits of technology, hand-in-hand with human expertise, offer exciting opportunities for accelerated document submission and overall clinical development.

At Bioscript Group, we’re integrating AI into our processes where it adds value, supporting the delivery of timely, robust submissions that ultimately benefit the industry and the patients we serve.

If you’re looking for support with your next clinical regulatory document or submission, or are simply curious about our approach to AI-enhanced writing and how it could benefit your team and work-flow, let’s talk.