Dark Horse Consulting Group
Dark Horse Consulting Group specializes in cell and gene therapy consulting, offering a wide range of services from product development to regulatory affairs and market analysis.
Services Offered by Dark Horse Consulting Group
Dark Horse Consulting Group delivers a wide array of services in the cell and gene therapy (CGT) sector. Their offerings encompass product and process development, analytical development, device development, manufacturing operations, quality assurance, and facility design and engineering. They also provide regulatory affairs, nonclinical development, project and program management, quantitative modeling, market expertise, and business strategy. This includes specialized services like comprehensive analytical support, regulatory support for device development, tech transfer and CDMO oversight, and failure analysis. Their services are designed to support clients throughout the entire lifecycle of their products, ensuring adherence to regulatory standards and operational excellence.
Expertise in Facility Design and Engineering
Dark Horse Consulting Group offers comprehensive facility design and engineering services. They provide strategic guidance for the development of flexible GMP clean room suites tailored to early-stage manufacturing clients. Their services include design reviews and optimization to ensure facilities comply with GMP standards. This creates a robust framework for clients to support their manufacturing needs, keeping regulatory compliance and operational efficiency at the forefront of their operations.
Regulatory Support in Cell and Gene Therapy
Dark Horse Consulting Group provides extensive regulatory support in the development and implementation of cell and gene therapy processes. Their services include regulatory gap analysis and assistance with global regulatory meetings. They offer strategic and tactical support throughout the regulatory compliance journey. For device development, they provide support in areas such as URS development, landscape scan and gap analysis, custom device design, and regulatory documentation, helping clients navigate the complex regulatory landscape effectively.
Quantitative Modeling with Pegasi Platform
The Pegasi platform is Dark Horse Consulting Group's proprietary quantitative modeling tool. It is used for data-driven decision-making across various aspects of cell and gene therapy projects. The platform offers capacity planning, cost of goods analysis, build vs. buy analytics, market analysis, and profit margin assessments. Pegasi supports clients in optimizing their business strategies and operational decisions, providing a robust analytical framework for tackling complex challenges in CGT.
Project and Program Management Services
Dark Horse Consulting Group provides detailed project and program management services to support the timely achievement of milestones and effective project governance. Their services include timeline analysis, project management, program development planning, and strategic portfolio prioritization. They offer interim functional leadership in key capabilities such as quality assurance, regulatory affairs, and project management, ensuring that clients' projects stay on track and meet all necessary regulatory and operational requirements.