Why Regulatory Culture Matters in Biotech
In early-stage biotech, it’s easy to assume that regulatory agencies across the EU, UK and US operate in a similar way. After all, they evaluate the same science, follow comparable international guidelines and ultimately pursue the same goal: bringing safe and effective therapies to patients. But as soon as a company begins preparing for real interactions, a meeting with the US Food and Drug Administration (FDA), a Scientific Advice with the EuropeanMedicines Agency (EMA), or an early dialogue with the UK’s Medicines andHealthcare products Regulatory Agency (MHRA), the differences become impossible to ignore. The EMA, MHRA and FDA speak the same scientific language, but each one brings its own culture, expectations and tempo. For biotechs developing across the EU, UK and US, these nuances quietly shape timelines, strategy and even the way data needs to be presented.
The FDA: Direct and process driven
The FDA is often seen as a more process driven Agency, with an extensive amount of guidance published. The first interaction with theFDA for an early-stage company is often a pre-IND meeting. This is a formal meeting, during which the preliminary plans for clinical development and the data and requirements to be able to start a clinical trial in the US are discussed. Recommendations issued by the FDA during the scientific consultations are regarded as binding, though the agency may reconsider its opinion once the new important data becomes available.
Different types of meetings are organised depending on the drug development stage and class. Separate sets of meetings are available for innovative prescription drugs, generics and biosimilars. To initiate a clinical study in the US, companies must submit the Investigational New Drug(IND) application, which contains data from pre-clinical studies, information on manufacturing process and clinical development plan for a candidate drug.
The EMA: Structured and Consensus-Driven
EMA, operates within a structured and consensus-driven environment. With 28 EU member states, together with Iceland and Norway, involved in Europe’s regulatory ecosystem, processes naturally become more formal and layered. Scientific Advice remains one of the most powerful tools available to companies developing in Europe. An important strategic choice for early-stage companies the decision to engage with EMA for Scientific Advice or to have a meeting with the regulatory authorities of the member states where the first-in-human trial will be performed. For early-stage biotechs, this is an important strategic assessment, and the right approach forms a solid foundation for its European regulatory strategy. Importantly, the feedback obtained inScientific Advice is not binding, and approach may change based on the later developments.
In the EU, the clinical trial application is submitted through a single application via a common electronic platform (Clinical TrialInformation System, CTIS), nevertheless it is reviewed by the national authorities in each of the member countries where the clinical trial is planned.
The MHRA: Agile and Surprisingly Flexible
The MHRA, shaped significantly by the post-Brexit landscape, has leaned into agility and competitiveness. The UK is currently positioning itself as one of the most innovation-friendly regulatory environments worldwide, offering accelerated procedures, shorter review timelines and a more flexible dialogue with emerging biotech companies. AS EMA and FDA, the MHRA offers the possibility for Scientific Advice to support companies in the development plan. The MHRA is also responsible for the approval of UK clinical trials.
While post-Brexit the MHRA has ‘left’ the European regulatory system, it still follows a broadly European approach to drug development, making the UK an attractive region for first-in-human studies or early-phase development. For small and mid-sized biotechs, this sometimes makes the MHRA the fastest way to build early momentum.
How These Differences Impact Your Development Strategy
Although these differences may seem subtle on paper, they influence nearly every stage of a company’s development. Cultural differences on risk/benefit acceptance on both sides of the Atlantic for example, can have a major impact on the design of your regulatory strategy. A development plan built around UK expectations might need additional justification before being accepted by EMA. In short, the sequence in which you engage with agencies and the way you present your scientific narrative can dramatically change your trajectory.
Regulatory Strategy as a Core Part of Early Development
For early-stage biotech, this means that regulatory strategy is not just a late-stage administrative requirement, it is a core part of your scientific, operational and commercial roadmap. One global product requires one global narrative, but that narrative must land with three very different regulatory cultures. Companies that identify divergence points early, harmonise their risk justifications and align their CMC, non-clinical and clinical plans across the EU, UK and US naturally move faster. Those that don’t often face avoidable delays, repeated questions and additional rounds of clarification.
How Aletheia Supports Biotechs Across the EU, UK and US
At Aletheia Life Science Consulting, we help early-stage biotech teams navigate exactly this complexity. By building clear, forward-looking regulatory strategies that bridge the expectations of the EMA,MHRA and FDA, we ensure that companies can present their data consistently, confidently and in a way that resonates with each region’s regulatory mindset.Whether you are preparing for Scientific Advice, drafting a pre-IND briefing package, planning your first-in-human study or simply trying to decide where to start your clinical journey, we bring the structure, clarity and regulatory insight needed to move from strong science to real-world impact.
Your innovation opens the door, but the strategy behind it determines how fast you get through.
