Dark Horse is uniquely positioned to provide both strategic and tactical regulatory assistance to our clients for their global regulatory needs. We are connected with current and former staffers of multiple, worldwide regulatory bodies, and have supported filings for clients across a wide range of global jurisdictions and stages of development. Our clients most frequently come to us for:
We help you plan for long term success, while maintaining a pragmatic focus on near term realities such as resource constraints and timeline objectives.
We provide an in-depth analysis of your current status and/or existing plan relative to requirements for your targeted milestone (e.g. readiness for INTERACT, pre-IND, IND/CTA, BLA/MAA), and provide you with a detailed report summarizing all identified gaps complete with severity rating and suggested remediations.
We organize and lead internal preparatory sessions for regulatory meetings, and also frequently attend regulatory meetings with our clients, to assist them in ‘putting their best foot forward’ with regulators.
We act as the US FDA Agent for clients based outside the US.
Our experienced technical writers can provide a full range of support for your filing needs, ranging from authorship of the full documents (or individual sections) to review, gap analysis, and editing of your existing draft documents. Our diverse team’s experience spans a wide range of global jurisdictions and stages of development, from preclinical (INTERACT, pre-IND, Scientific Advice, IND, IMPD, CTA) through clinical (pre-Phase, End-of-Phase, amendments, RMAT, PRIME) and marketing approval (BLA, MAA).