Consulting

Interim Leadership Positions

Bridging leadership gaps with expert interim support. Our interim executives provide immediate expertise to maintain momentum, drive strategic initiatives, and support growth in cell and gene therapy companies.

Ensuring Stability and Strategic Direction with Interim Leadership

Leadership gaps can disrupt operations, slow decision-making, and impact regulatory compliance. In the fast-moving cell and gene therapy sector, companies must maintain strategic oversight, operational continuity, and technical expertise to stay competitive. Whether due to rapid growth, leadership transitions, or specific project needs, securing interim leadership ensures stability and progress without disruption.

An effective interim leadership solution provides specialised expertise, regulatory guidance, and strategic direction to keep operations aligned with business goals.

Our Process

Specialised Knowledge and Expertise

Cell and gene therapy companies require leaders with deep scientific, regulatory, and commercial knowledge. Our interim experts bring extensive experience in biotechnology, regulatory affairs, and manufacturing, ensuring smooth transitions and effective decision-making.

Regulatory and Compliance Oversight

Navigating evolving regulations is critical to success. Our interim leaders help companies maintain compliance with global regulatory agencies, avoiding delays in clinical trials, approvals, and commercialisation.

Strategic Focus and Decision-Making

Without clear leadership, companies risk misaligned priorities, missed opportunities, and operational inefficiencies. Our interim executives provide the vision and direction needed to drive long-term success.

Operational Continuity and Growth Support

Interim leaders keep projects on track, oversee resource allocation, and provide guidance on technology transfer, manufacturing scale-up, and process optimisation, ensuring business continuity.

Our Approach

We provide interim leadership tailored to the needs of each company, ensuring expertise in operational management, technical knowledge, strategic planning, and regulatory oversight. Our interim executives integrate seamlessly into teams, providing immediate, high-level support across key areas of business.

Manufacturing Strategy and Capacity Planning

Developing long-term manufacturing strategies, overseeing facility planning, and optimising resource allocation to support clinical and commercial scale-up.

Regulatory and GMP Compliance Leadership

Supporting regulatory submissions, compliance with Good Manufacturing Practice (GMP) requirements, and quality assurance oversight to maintain alignment with agency expectations.

Technical and Scientific Expertise

Providing technical leadership in process development, analytical sciences, and non-clinical and clinical strategy to guide product development and regulatory approvals.

Business Continuity and Transition Management

Filling leadership gaps during critical transitions, supporting executive recruitment, and ensuring key projects remain on schedule during leadership changes.

Service Benefits

Seamless Leadership Transitions

Maintain operational stability and strategic oversight during leadership changes.

Regulatory Confidence

Ensure compliance with evolving global regulations to avoid delays.

Strategic Growth and Risk Mitigation

Align business strategy with industry best practices to support long-term success.

Immediate Expertise

Access highly experienced leaders without long recruitment cycles.

Key Deliverables

Interim executives with sector-specific experience

Leadership support in regulatory, technical, and operational areas

Business continuity planning and risk mitigation

Manufacturing and supply chain strategy development

GMP compliance and regulatory leadership

Keep Your Business Moving Forward

Interim leadership plays a vital role in ensuring stability and growth for cell and gene therapy companies. Whether filling short-term leadership gaps, driving regulatory strategy, or guiding manufacturing expansion, our interim executives provide immediate, expert support tailored to your needs. Contact us today to discuss how our interim leadership solutions can support your company’s success.

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Other 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.

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.

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.

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.