Strategic Advisory & Enablement
We are not traditional consultants. We are a team of seasoned biomanufacturing leaders who have built and scaled the industry’s most complex therapies. Our advisory services are grounded in this operational reality. We partner with you to implement the strategies and technologies that de-risk programs, accelerate timelines, and build lasting manufacturing capabilities.
Core Areas of Expertise
CMC & Manufacturing Strategy
We provide comprehensive CMC strategy, from process design and development to full-scale manufacturing oversight. Our expertise spans RNA, DNA, viral-based systems, and other advanced modalities, ensuring your program is built on a robust and scalable foundation.
Facility Design & Capital Strategy
Leveraging our proprietary FAST GMP™ principles, we guide you through facility design, tech transfer, and capital strategy. We specialize in creating flexible, capital-efficient infrastructure designed for speed and future adaptability.
AI & Digital Integration
We guide the integration of AI and digital systems to solve operational bottlenecks. Our expertise includes deploying intelligent platforms that unify disparate systems (MES, LIMS) and using AI-driven insights to optimize processes for yield, quality, and compliance.
Regulatory Enablement
We provide strategic guidance to navigate complex global regulatory pathways. Our approach leverages data-driven insights and deep operational experience to prepare and support robust regulatory filings, accelerating your path to approval.
