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.
We provide an in-depth analysis of your current status and/or existing plan relative to requirements for your targeted milestones (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 help you plan for long-term success, while maintaining a pragmatic focus on near-term realities such as resource constraints and timeline objectives.
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. Includes briefing book support, pre-meeting preparatory workshops, direct meeting assistance & participation, and meeting minuting.
We act as the US FDA Agent for clients based outside the US.
For clients currently without internal leadership focused on this domain, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.
We oversee achievement of your project milestones, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable,consulted, informed) matrices, and following up on achievement of action items.