Regulatory Strategy as Competitive Advantage: From Compliance to Acceleration

Authors: Ronald Ullers and Vi Stuart 

For many years, regulatory affairs were viewed as a necessary hurdle in drug development. The role was to ensure compliance, prepare dossiers, and shepherd submissions through complex national and international frameworks. That perception is outdated. Today, regulatory strategy is not simply about compliance; it is a source of competitive advantage. When integrated early into drug development planning, regulatory expertise can accelerate timelines, de‑risk programmes, and even enhance the commercial value of a compound. 

At hVIVO, our regulatory experts have seen this transformation first‑hand. Their experience across early‑phase clinical trials, human challenge studies, and complex therapeutic areas has shown that regulatory affairs are no longer confined to the back room. They are central to shaping development pathways, influencing policy, and ensuring that innovative treatments reach patients more quickly. 

Compliance and Acceleration: Two Sides of the Same Coin 

Compliance remains the foundation. Without robust documentation — CTAs, INDs, eCTDs, and GxP validation — no programme can progress. But acceleration is achieved when a well‑designed regulatory strategy is embedded from the outset. By starting with a Target Product Profile (TPP) and a tailored regulatory roadmap, sponsors can align indication, population, and endpoints before committing significant resources. This proactive approach avoids costly missteps and ensures that development remains focused on the end goal. 

Our teams emphasise that regulatory strategy is not a static checklist. It is a living plan, adaptable to scientific progress and commercial realities. By involving regulatory experts early, sponsors gain clarity on what is feasible, what is acceptable to regulatory agencies, and how best to position their product for success.   

Expedited Pathways as Strategic Assets 

Regulatory designations such as FDA Fast Track, EMA PRIME, and orphan status are more than badges of honour. They are strategic assets that accelerate development and increase commercial value. Smaller biotechs use them to attract investors and partners; larger pharmaceutical companies use them to reduce time to market. 

Our regulatory consultants have guided sponsors through these pathways, helping them secure designations that transform the trajectory of a programme.  An example being a universal flu vaccine application for the EMA PRIME scheme. These expedited pathways demonstrate how regulatory strategy can directly influence both scientific progress and commercial outcomes. 

The Importance of Relationships and Influence 

Technical expertise alone is not enough. Regulatory success depends on relationships — with agencies, with sponsors, and with policymakers. Our experienced consultants know how to prepare briefing packages, rehearse meetings, and manage interactions with regulators. They understand that clarity and simplicity are essential, particularly when agencies operate under tight review timelines. 

Human challenge studies illustrate this point. These models are not yet fully codified in regulatory guidance, and acceptance varies. By engaging regulators directly, explaining the science clearly, and lobbying for greater and wider inclusion in guidance, our teams have helped broaden acceptance of challenge models. This is regulatory strategy in action: building trust, influencing policy, and creating pathways for innovation that would otherwise be blocked. 

Human Challenge Studies: A Case Study in Strategy 

Challenge models are sometimes viewed as less rigorous than field trials. Yet they provide invaluable proof‑of‑concept data, de‑risking later development and accelerating vaccine and antiviral programmes. Regulatory strategy is what makes them acceptable. By positioning challenge studies as controlled, ethical, and scientifically robust, and by aligning endpoints with field trial triggers where applicable, our experts have secured regulatory confidence. 

The future lies in broadening this acceptance — into patient populations, later phases, and new therapeutic areas. Achieving this requires not only scientific excellence but also regulatory advocacy. It is a clear example of how strategy transforms compliance into competitive advantage. 

Integration Across the hVIVO Group 

Another key strength is its integrated approach. hVIVO’s regulatory services operate seamlessly across CMC, non‑clinical, and clinical consultancy. Our senior experts do the work themselves, supported by a network of specialists across the group.  Delivery is not delegated to junior or less experienced team members. This breadth and depth mean sponsors receive end‑to‑end support, from consultancy and operational support for IND‑enabling toxicology packages to marketing authorisation dossiers. 

Integration ensures consistency and quality across the development lifecycle. It also allows sponsors to benefit from cross‑functional expertise, whether in infectious or respiratory disease, cardiometabolic research, or complex combination products. This holistic approach is rare in the industry and represents a genuine competitive advantage. 

Looking Ahead: Strategy as Partnership 

Regulatory strategy is evolving. Early adaptive designs, master protocols such as umbrella, platform protocols, and real‑world evidence are reshaping the landscape. Agencies are increasingly open to innovative approaches, but only if sponsors can present them clearly and convincingly. We would emphasise that the role of regulatory affairs is now as much about communication and negotiation as it is about documentation. 

The future is about partnership. Regulators encourage dialogue, sponsors seek acceleration, and experienced service providers act as the bridge. By combining technical expertise with relational skill, regulatory professionals can influence guidance, shape policy, and accelerate innovation. 

Conclusion 

Regulatory affairs are no longer the obstacle they were once perceived to be. With the right strategy, they become a lever for speed, credibility, and commercial success. Compliance is essential, but acceleration is where competitive advantage lies. Expedited pathways, strong relationships, and integrated expertise all contribute to a regulatory strategy that does more than satisfy requirements — it drives innovation forward. 

At hVIVO, we believe that regulatory strategy is not optional. It is the difference between delay and success, between uncertainty and confidence. For sponsors, partnering with experienced regulatory experts is not just about meeting obligations. It is about gaining a competitive edge in the race to deliver better therapies to patients. 

About the authors  

Ronald Ullers, Senior Consultant Regulatory Affairs CMC.  Ronald holds a Ph.D. in molecular microbiology and brings 18+ years of experience in the biopharmaceutical industry. He specialises in regulatory affairs with a focus on chemistry, manufacturing, and control (CMC) for a diverse range of biotech products, vaccines, ATMP’s and small molecules.  

Vi Stuart, Regulatory Affairs Consultant. Vi is a seasoned global regulatory affairs leader having 25+ years of experience across Roche, Eisai, GSK, Cancer Research UK, and Paraxel specialising in respiratory and oncology therapy areas.  She is a passionate advocate for regulatory innovation, including decentralized trials, real-world evidence, and digital endpoints.