Our Services

Consulting

From CMC strategy to regulatory compliance and leadership support, our consulting services help cell and gene therapy developers navigate complexity, reduce risk, and move with confidence from concept to clinic.

Strategic Expertise to Accelerate CGT Development

Developing a cell or gene therapy requires more than GMP capacity. It demands deep scientific insight, regulatory understanding, and commercially aligned decision-making, particularly in the early phases of development.

Our Consulting team provides expert guidance to biotech innovators, academic groups, and established biopharma companies, supporting them at every stage of development.

Whether you need help shaping your CMC (Chemistry, Manufacturing, and Controls) strategy, preparing for due diligence, optimising cost of goods, or securing a QP (Quality Person) for batch release, our team provides the knowledge and experience to keep your programme moving forward.

We also offer senior interim leadership support across technical, regulatory and manufacturing roles. This gives you the flexibility and expertise to fill critical gaps when they matter most.

Our Consulting Services

CMC Strategy

A well-defined CMC strategy is essential for accelerating development while ensuring compliance, quality, and cost efficiency. We help define your product’s Target Product Profile, align development plans with regulatory expectations, and create a roadmap that supports long-term success.

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Cost of Goods

Early decisions significantly impact a therapy’s future commercial viability. Our cost modelling expertise helps our clients optimise manufacturing strategies, reduce risk, and build a strong economic foundation for scale-up and commercial production.

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GMP Compliance & QP Services

Ensuring regulatory compliance is non-negotiable in advanced therapies. Our experienced QPs provide batch certification, GMP oversight, and compliance consulting, supporting your manufacturing processes to meet strict quality and safety standards.

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Interim Leadership Positions

Short-term leadership gaps can disrupt critical operations. We provide interim executives and technical leaders with deep sector expertise to help maintain momentum, drive key initiatives, and strengthen operational strategy during transitional periods.

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Investor & Technical Due Diligence

Cell and gene therapies offer life-changing potential, but rapid advancements make it challenging for investors to assess technical risks. We provide independent, data-driven evaluations of company capabilities, manufacturing feasibility, and regulatory positioning, ensuring that investment decisions are backed by expert insight. Whether assessing the scalability of a therapy, the viability of a manufacturing process, or the scientific validity of a therapy, we help investors and stakeholders make informed, confident decisions.

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Why Partner With Us?

Integrated Expertise

A seamless blend of CDMO capabilities and consulting services, ensuring a strategic, end-to-end approach.

Industry-leading Guidance

With over two decades of expertise, we deliver bespoke solutions that align with your specific technical, regulatory, and commercial needs.

Regulatory & Commercial Insight

Helping clients de-risk development while maintaining a clear route to market.

True Flexibility & Collaboration

From single projects to long-term partnerships, our consultants integrate with your team, offering tailored support without restricting your freedom to scale.

Proven Track Record

70% repeat business rate, demonstrating long-term client trust and successful project outcomes.

Let’s Move Your Therapy Forward

Whether you are an emerging biotech, an established company, or an investor assessing opportunities, our Consulting team is here to help. Contact us today to discuss how we can support your development and manufacturing journey.