Regulatory
OWL provides flexible regulatory experts without the overhead of full-time staffing. Whether you need targeted support for submissions, strategy, or agency interactions, our professionals integrate directly into your team to ensure filings are done right the first time, saving time, reducing risk, and protecting approvals. OWL has guided sponsors through global submissions across North America, Europe, Australia, and beyond.
Flexible Regulatory Staffing
Hiring full-time regulatory staff can be costly and inefficient, especially for sponsors with fluctuating pipeline needs. With OWL, sponsors get experienced regulatory professionals on-demand, providing high-quality support for submissions, strategy, and agency interactions. Our fractional model provides flexibility, expertise and scalability without long-term commitments or the burden of managing regulatory headcount.
Regulatory Expertise Saves Time and Money
Regulatory missteps can cause delays, trigger costly rework, or risk approvals. OWL provides specialized, senior regulatory professionals who integrate seamlessly with your team. We prioritize sponsor interests and assign consistent experts to ensure submissions, filings, and responses are done right the first time.
Global Regulatory Support
One of the biggest obstacles to later-phase global expansion is navigating international regulatory requirements. OWL has supported many clients through regulatory submissions in North America, Europe, and Australia with additional support available in other regions. We have experts ready to help with submissions to FDA, MHRA, EMA (CTIS I & II), the Australian TGA, and more.
Proactive Planning for Global Success
Successful regulatory execution starts well before submission. OWL helps sponsors anticipate regional requirements, align protocols with agency expectations, and prepare for milestone interactions across jurisdictions. Whether you're advancing a first-in-human study or expanding into new markets, our regulatory experts provide strategic foresight and operational support to help you stay ahead—reducing risk, accelerating timelines, and maximizing the value of your clinical development strategy.