Partners Who Make AI-Powered Document Authoring Work

When I read McKinsey’s article, Rewiring Pharma’s Regulatory Submissions with AI and Zero-Based Design, I couldn’t help but feel a mix of excitement and cautious optimism. As someone who’s spent my career immersed in medical writing and project management—and as a certified Disciplined Agile Scrum Master (DASM)—I’m all for innovations that make processes more efficient and effective. AI-powered document authoring and zero-based design offer the potential to fundamentally reshape how regulatory submissions are developed, reviewed, and delivered. 

But here’s the thing: transformation isn’t just about adopting shiny new tools. It’s about challenging assumptions, rethinking workflows, and making sure the human element doesn’t get lost in the shuffle.  

Zero-Based Design: Redefining the Foundation, Not Just Starting Over 

Zero-based design isn’t just about wiping the slate clean and starting fresh—it’s about taking a hard look at existing processes, questioning every assumption, and rebuilding workflows with intention. It’s not enough to tweak what’s already in place; zero-based design asks you to go deeper. What steps are truly necessary? Where are inefficiencies lurking? What assumptions are holding teams back from working smarter? 

In the context of regulatory submissions, this might mean rethinking how clinical documentation AI tools can be integrated into workflows to automate repetitive tasks, eliminate redundancies, and enhance collaboration across teams. Document automation in biotech companies could streamline the way data are gathered, reviewed, and compiled, ensuring submissions are both efficient and impactful. Zero-based design provides a framework to address these questions systematically, helping teams build processes that are leaner, more agile, and better aligned with their goals. 

As a DASM, I see zero-based design as a natural extension of agility. It’s about tailoring workflows to fit the unique needs of a project, rather than forcing a one-size-fits-all approach. And when paired with AI-powered document authoring, zero-based design has the potential to unlock new levels of efficiency and precision. But, as exciting as this sounds, it’s not without its challenges. 

When Innovation Meets Reality: The Challenges Behind the Promise of AI-Powered Document Authoring

McKinsey’s vision of AI and zero-based design in pharma is inspiring, but it’s also ambitious—and ambitious ideas often come with hurdles. In an article I contributed to in the AMWA Journal, integrating agile principals into regulatory writing. These same challenges apply to zero-based design. Here are a few that stand out: 

Data Integrity Is Non-Negotiable

AI relies on high-quality data to deliver meaningful insights. If the data are incomplete, inconsistent, or poorly structured, the entire process risks being derailed. Zero-based design can help address this by identifying and fixing data bottlenecks upfront, but it requires careful planning and execution. 

Compliance Is Always King

Regulatory submissions aren’t just about speed or efficiency—they’re about meeting stringent guidelines. AI tools, including clinical documentation AI tools, need to be designed with compliance in mind, and human oversight is essential to interpret the nuances of evolving regulations.  

Change Is Hard

Implementing new methodologies isn’t just a technical challenge—it’s a cultural one. Teams need time to adapt to new workflows, and without proper training and buy-in, even the best-designed processes can fall flat. It doesn’t matter how fast you produce a document with AI if your review cycles are eating up that time on the back end. 

The Human Element Matters

AI can automate tasks and flag issues, but it can’t replicate the expertise, judgment, and storytelling skills that medical writers bring to the table. Regulatory submissions require a level of nuance that only comes from experience. Not all humans are well equipped (or trained) to work in agile circumstances, so this requires an intentional approach from a staffing and development standpoint. 

These challenges don’t mean innovation isn’t worth pursuing—they simply highlight the importance of approaching transformation with care and intentionality. 

Partners Who Make Innovation Work 

At my company, Synterex, we don’t just implement new tools or methodologies for the sake of it—we help our clients navigate the complexities of change, ensuring that innovations like AI-powered document authoring and zero-based design are applied thoughtfully and effectively. 

Here’s how we do it: 

Strategic AI Integration

We work with clients to identify where AI-powered document authoring and clinical documentation AI tools can add the most value and ensure they’re paired with human oversight to maintain quality and compliance. 

Regulatory Expertise

Our team stays on top of evolving guidelines, ensuring that submissions not only meet requirements but also tell a compelling, scientifically accurate story. 

Process Redesign

Using agile methodologies and zero-based design principles, we help clients eliminate inefficiencies and build workflows that are tailored to their needs. 

End-to-End Support

From preclinical documents to marketing applications, we provide comprehensive support to ensure submissions are impactful and reviewer friendly. 

Ultimately, our goal is to help clients embrace innovation without losing sight of what matters most: quality, compliance, and the human touch. 

Looking Ahead: Balancing Innovation with Expertise 

AI-powered document authoring and zero-based design have the potential to transform regulatory submissions—and as someone who’s passionate about both agility and medical writing, I’m excited to see where these methodologies take us. But transformation is never easy, and it requires more than just technology. It takes thoughtful planning, skilled execution, and a commitment to balancing innovation with expertise. 

Ready to Rethink Your Regulatory Submissions? 

At Synterex, we’re proud to help pharma companies navigate this journey. Whether you’re looking to streamline workflows, integrate document automation in biotech companies, or simply deliver better submissions, we’re here to make it happen. Let’s work together to turn ambitious ideas into practical solutions—and ensure that innovation doesn’t come at the expense of quality. 

If your organization is exploring AI-powered document authoring, zero-based design, or other ways to improve regulatory submissions, let’s talk.