Drug developers increasingly have the option of seeking regulatory approval and commercializing a medicine themselves, rather than accepting an early exit offer. Doing so requires a worldwide strategy.
The biotech funding rebound presents a strategic choice for small drug developers that was not available during the post-pandemic slump. Rather than accept an early partnership or acquisition to keep the lights on, many companies now have the funding runway to retain their assets longer and advance them further on their own. But exercising that independence increasingly requires a global regulatory strategy with parallel submissions.
In my position at Parexel, I’ve worked directly with biotech CEOs who recognize that executing this strategy demands a level of regional reach their companies do not have in-house. They’re looking for help in navigating this new regulatory playbook. They understand that seeking approval overseas is not a replacement for the FDA pathway; it’s a parallel and necessary approach. Pursuing approvals in multiple markets simultaneously allows sponsors to de-risk their dependence on any single agency while also accelerating patient access globally.
The FDA is still the regulatory anchor, but others are growing more competitive
The FDA and regulators in other major markets have been making deliberate moves to streamline their processes and attract development activity. The result is a regulatory landscape that looks meaningfully different from the one companies were operating in even a few years ago.
In the U.S., the FDA continues to incentivize high-value, differentiated programs, including through unmet need designations, orphan drug status and personalized medicine. In this environment, the clarity of a submission is key, as a poorly constructed dossier or an insufficiently justified development plan carries greater risk of delay or rejection.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has opened up to global assets, adding offices in the U.S. in late 2024 to provide consultation and support for overseas companies with no presence in Japan. The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has cleared its backlog and just rolled out new regulations governing the clinical trial application process, with timelines that are now beating the FDA. The European Medicines Agency (EMA) has similarly become more attractive for parallel engagement, launching EU-CTR to support single-application, multi-country trial approvals. The agency has initiated several pilot projects, such as FAST-EU, to accelerate trial authorization.
This competitive global dynamic is reshaping where and how biotechs pursue development. Historically, the path was sequential: secure FDA approval first, then expand to the EMA, and finally to other regions, often much later. Now, parallel submissions are becoming the norm.
These require more than filing to multiple agencies at once. They require parallel regulatory input on your development plan from the start. Multi-regional perspectives must be built into protocol design, not incorporated at the point of filing. Failure to integrate early will almost inevitably lead to inefficiencies, delays or sub-optimal global outcomes—risks that are disproportionately impactful for smaller organizations. For a small company without expertise in every region, this process can be a significant strain.
Execution risk is real
Choosing to advance independently is a significant operational undertaking. Many companies have never navigated Phase 2 and Phase 3 with the FDA on their own. They lack bandwidth across multiple regions and are running trials in an environment where clinical sites are saturated and investigator costs are rising due to inflation.
Given this, flawless operational execution has never mattered more. There is little margin for error when a regulatory agency is operating under capacity constraints and resubmission is costly. A well-designed, derisked submission is no longer just good practice; it is critical risk management.
Biotechs are no longer deliberating between the traditional options of seeking a partner or an acquisition. They must build global development plans from day one with parallel submissions as a core element, not as something they can address once the FDA path is established.
The regulatory landscape has shifted in ways that make the independent path more viable, but only for those who plan and execute with rigor and the right infrastructure. This will ensure parallel submissions are not just feasible, but strategically optimized.
