Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringMaking the right investment or technical decision in cell and gene therapy requires expert insight. Our due diligence assessments provide independent, data-driven evaluations to help you navigate risk and unlock opportunity.
Consulting
Investor & Technical Due Diligence
How Does Due Diligence Drive Informed Decisions?
Cell and gene therapies offer the potential for life-changing cures, but rapid innovation makes it difficult for investors and companies to assess risks and opportunities. Whether you’re investing in a biotech start-up, evaluating a potential acquisition, or validating a new technology, a structured due diligence process is essential for making informed, confident decisions.
A well-executed due diligence strategy identifies technical, regulatory, and commercial risks before they impact your investment or development plan.
Our Process
Safety & Efficacy
Novel therapeutic approaches bring both potential and uncertainty. Our due diligence process evaluates scientific robustness, manufacturing feasibility, and regulatory alignment to ensure therapies meet critical safety and efficacy standards.
Quality & Manufacturing Readiness
CGT production must meet stringent Good Manufacturing Process (GMP) requirements. We assess manufacturing processes, facility compliance, and scalability to determine if a product can transition smoothly from clinical to commercial production.
Investment Protection
Investors need a clear picture of financial risk. Our evaluations uncover potential pitfalls in scientific claims, operational strategies, and regulatory positioning, ensuring investments are based on solid data, not speculation.
Supply Chain Resilience
The availability of raw materials, viral vectors, and critical components can impact timelines and costs. We identify vulnerabilities and provide risk mitigation strategies to strengthen supply chain security.
Scalability & Market Viability
A promising therapy is only as successful as its ability to scale. We assess whether the development and manufacturing plans align with commercial viability, ensuring a realistic path to market.
Our Approach
We combine technical expertise with commercial foresight to provide a comprehensive due diligence service. Our independent assessments help investors, biotech companies, and pharma partners evaluate opportunities with confidence.
By evaluating key areas outlined below, we provide you with the insights needed for informed, strategic decision-making.
Service Benefits
Informed and Strategic Decision-Making
Gain a clear, data-backed understanding of risks and opportunities, ensuring investment and technical decisions are based on solid evidence.
Risk Mitigation and Market Positioning
Identify potential pitfalls in technology, regulatory strategy or operations while validating scalability and commercial potential for long-term success.
Confidence in Manufacturing and Compliance
Assess GMP readiness, production feasibility and regulatory alignment to ensure a smooth transition from clinical development to commercial manufacturing.
Independent and Unbiased Insights
Receive expert, impartial evaluations that provide objective recommendations, free from internal biases. Each project is managed through a dedicated single point of contact, ensuring seamless communication and expert guidance throughout the process.
Key Deliverables
Gain Clarity & Confidence in Every Decision
With independent technical and investor due diligence, you can make informed choices that align with your strategic goals. Whether you’re considering an investment, acquisition, or partnership, our expertise ensures you have the insights needed to move forward with confidence. Speak with our team today to discuss how our due diligence services can support your next move.
