Empowering Early-Stage Cell and Gene Therapy (CGT) Companies to Scale and Grow

Navigating the complex landscape of cell and gene therapy can be challenging for early-stage companies. From insufficient document management to a lack of clear framework, all the way through needing expert regulatory submission insights, it can be difficult for Cell and Gene Therapy organizations to find the necessary support and tools to navigate the commercialization process alone.

Introducing the Cell and Gene Therapy In-a-Box Solution

Developed in collaboration with IQVIA, Cell and Gene Therapy In-a-Box Solution is your comprehensive playbook designed to guide CGT organizations through the commercialization pathway with essential tools and support.

Cell and Gene Therapy In-a-Box Solution Includes:

  • Customized Roadmap: Navigate key events in bringing a product to market with a clear, step-by-step plan.
  • Cross-Functional Orchestration: Leverage standardized best practices, support, and planning for submission and inspection readiness.
  • Knowledge Management Platform: Enjoy validated document storage and a comprehensive audit trail for regulatory compliance and version control.

And so much more.

Equip your company with a clear understanding of foundational success factors and potential roadblocks for successful product submission. Plus, benefit from a tailored plan specific to your organization’s needs and access expert support throughout, so your team isn’t moving through the process alone.

Discover RegDocs365’s CGT In-a-Box Solution

RegDoc365’s CGT In-a-Box is a fully 21 CFR Part 11 compliant, cost-effective content and document management solution hosted in an Audit Ready Compliant Cloud (ARCC) validated environment.

Key Features:

  • Centralized Content Management: Manage all digital content, including documents, data, voice, and video, to streamline the commercialization process from discovery through post-market.
  • Inspection-Ready Documentation: Ensure your documentation is ready for quick and accessible audit or regulatory requests.
  • Complete Compliance Tools: Folder structures, checklists, workflows, alerts, and audit trails to help meet Good Management Practices and regulatory requirements.

RegDocs365 & IQVIA offer an integrated solution that includes:

  • Project Management
  • Calendar Setup
  • Internal and External Collaboration Capabilitie
  • Security and Data Governance
  • Document Library Repository
  • Dashboards for Quick Analysis

About Court Square Group

At Court Square Group, we specialize in Audit Ready Compliant Cloud Infrastructure solutions for the life sciences industry. Our cloud, collaboration, and regulatory submission solutions reduce costs, complexity, and risks associated with sharing, storing, and submitting information for regulatory requirements at every development and manufacturing lifecycle stage.

Ready to streamline your cell and gene therapy commercialization journey? Contact us today to learn how CGT- In-a-Box can transform your business.

We are usually asked about

What is “Cell & Gene Therapy in a Box”?

Cell & Gene Therapy in a Box is a pre-configured, validated technology framework designed to support regulated CGT development. It combines compliant cloud infrastructure, security, documentation, and operational controls to help teams stand up quickly without building systems from scratch.

Who is Cell & Gene Therapy in a Box designed for?

It is designed for early-stage and growing cell and gene therapy companies, including startups, virtual biotechs, and emerging clinical teams. These organizations need compliant infrastructure fast but often lack internal IT, QA, and validation resources.

What problems does Cell & Gene Therapy in a Box solve?

It addresses common CGT challenges such as long infrastructure timelines, fragmented systems, audit readiness gaps, and compliance risk. The approach reduces delays by providing a structured, ready-to-use foundation aligned with regulated development requirements.

How does Cell & Gene Therapy in a Box support regulatory compliance?

The framework is built around validated systems, documented controls, and regulated best practices aligned with FDA and global regulatory expectations. This helps teams maintain inspection readiness while supporting GxP-adjacent and GxP workflows.

How is this different from using generic cloud or SaaS tools?

Generic tools often lack validation, documentation, and security controls required in regulated CGT environments. Cell & Gene Therapy in a Box focuses on compliance-ready architecture, reducing the need for retroactive fixes during audits or clinical progression.

Can Cell & Gene Therapy in a Box scale as programs move into the clinic?

Yes. The framework is designed to scale alongside clinical and operational growth, supporting increased data volume, users, and regulatory scrutiny as programs advance toward IND and beyond.

Why is compliant IT infrastructure critical for cell and gene therapy companies?

Cell and gene therapy programs operate in highly regulated environments where data integrity, security, and traceability are essential. Non-compliant infrastructure can delay trials, increase audit risk, and create costly remediation later.

What regulations impact technology systems used in cell and gene therapy?

CGT companies are affected by regulations such as FDA 21 CFR Part 11, GxP principles, data integrity guidance, and global privacy and security standards. Technology systems must support validation, access control, audit trails, and documentation.

Dive In

Cell and Gene Therapy In-a-Box for Life Sciences: Empowering Early-Stage CGT Companies to Scale and Grow
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