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REGULATORY SUPPORT

Dark Horse is well equipped to provide both strategic and tactical regulatory assistance to our clients. 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:

Regulatory Strategy:
We help you plan for long term success, while maintaining pragmatic focus on near term realities such as resource constraints and timeline objectives.

Filing Assistance:
We have extensive experience with planning, authoring and submitting worldwide regulatory filings for a wide variety of Cell and Gene Therapy products.

Meeting Assistance:
We frequently attend regulatory meetings with our clients, to assist them in ‘putting their best foot forward’ with regulators.

Dark Horse is well equipped to provide both strategic and tactical regulatory assistance to our clients. 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:

Regulatory Strategy:
We help you plan for long term success, while maintaining pragmatic focus on near term realities such as resource constraints and timeline objectives.

Filing Assistance:
We have extensive experience with planning, authoring and submitting worldwide regulatory filings for a wide variety of Cell and Gene Therapy products.

Meeting Assistance:
We frequently attend regulatory meetings with our clients, to assist them in ‘putting their best foot forward’ with regulators.

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