Our Expertise
CellSpark Consulting guides its industry partners to navigate the complex journey of bringing therapies to the market. Our team provides expert guidance in validation, regulatory compliance strategy, technology transfer, and process optimization, helping our industry partners achieve operational excellence and effortless regulatory compliance.

About Us
Temperature Mapping
CellSpark specializes in comprehensive temperature mapping and thermal validation services. Our expertise ensures that all client facilities and equipment, from large distribution warehouses to high-performance freezers, consistently meet strict regulatory, internal quality, and product safety standards.

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Commissioning & Qualification Services
We provide comprehensive, end-to-end commissioning and qualification services, complete with dedicated project supervision and oversight. This ensures seamless stakeholder coordination, clear communication, and disciplined execution throughout every project phase.

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Validation Services
We assist our partners in developing structured, risk-based validation programs that are sustainable, inspection-ready, and fully compliant with regulatory expectations. Our methodology is built upon ICH Q8/Q9/Q10 principles, GAMP 5 guidance, and industry best practices including ISPE Baseline Guides and ASTM E2500.

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Automation Engineering
We deliver specialized Automation services to our industry partners, emphasizing seamless integration, system reliability, and comprehensive compliance from initial design through final validation.

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Quality & Compliance
We offer Quality and Compliance expertise to support the development, manufacturing, and commercialization of your advanced therapy products. Our experts are dedicated to ensuring your operations meet global regulatory expectations while fostering a culture of quality and continuous improvement.

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Technology Transfer
We deliver structured, compliant, and knowledge-driven Technology Transfer Services that ensure your processes, products, methods, and critical knowledge are seamlessly transferred between development and manufacturing sites, whether internally or across CDMO networks.

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Technical Writing
At CellSpark, we specialize in translating complex scientific and regulatory information into clear, structured, and inspection-ready documentation. Our technical writing services are purpose-built for the pharmaceutical, biotechnology, and cell & gene therapy sectors, ensuring your operations are audit-ready and your teams are aligned from development through commercialization.

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Project Management
We offer SME-driven project management for complex, multi-site initiatives. We ensure your projects are delivered within a structured, GxP-aligned framework, focusing on minimizing risk, mitigating regulatory challenges, and seamlessly integrating new processes into your current operations. We manage transfers across all development and commercial stages, ensuring every step is traceable, audit-ready, and defensible.

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Procurement
Clients partner with us to avoid costly procurement delays that can derail validation or technology transfer timelines. We ensure all purchased items are fit-for-GxP and audit-ready from the outset. By embedding procurement within your Quality Management System (QMS) and project frameworks, we significantly reduce vendor-related quality risks. Furthermore, our clients gain access to domain-specific expertise during the vendor evaluation process, going beyond the capabilities of generalist procurement teams.

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Precision Driven & Compliance Focused

Empowering Bio-Science with Precision Consulting. Let’s Shape the Future of Life Science Together.

Our Full Services

Ignite Ideas
Accelerate Innovation
Deliver Real Results

“From emerging biotech to global pharma, we partner with life sciences leaders to accelerate innovation, ensure compliance, and deliver trusted expertise.”

At CellSpark, our PMP and PMI-ACP certified consultants provide expert project leadership with agile flexibility. We help our partners navigate complex pathways to market with confidence, ensuring their initiatives achieve optimal outcomes with precision and speed.

From The Founder's Desk

Welcome to CellSpark Consulting Inc.! We are excited to share the journey behind our firm and the purpose that drives our work. When we founded CellSpark, our vision as a company was clear—to build a consulting practice where deep scientific expertise, regulatory insight, and operational excellence come together to deliver high-impact solutions for the life sciences industry. With a strong foundation in pharma and biotech, CellSpark is dedicated to advancing innovation, ensuring compliance, and supporting our clients through every stage of the product and project lifecycle.
At CellSpark Consulting Inc., we believe in the power of collaboration and the value it brings when scientific, regulatory, and operational expertise come together with a shared purpose. Whether you’re a biotech startup navigating early-phase development or an established pharmaceutical company aiming to optimize and scale, we’re here to support your vision with strategic, compliant, and impactful solutions tailored to every stage of your journey.

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