10.10.25 -- Advance Your Regulatory Submission With Expert Support And Tools

Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support to help advance and facilitate your documentation progress.

Accelerate and streamline your validation process with technical project management of your lab's analytical validation. Our consulting services provide technical project management of your lab’s AV, potentially reducing your overall time to launch by 75%.

This award-winning, automated bag-filling platform provides fully automated, closed, and flexible bag filling in class C or D cleanroom settings.

Learn about CQV services supporting every stage of your facility's lifecycle, including design, construction, startup, operation and maintenance to ensure seamless compliance and efficiency.

This tool is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. It enables centralized monitoring, customizable alerts, and secure data access.

Explore growth factors and cytokines for regenerative medicine and cell and gene therapies offered in both GMP and preclinical grades for research and clinical use.

Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.

Review data collection system, software, and controls that should be considered with each institution's policies and procedures to achieve compliance with 21 CFR Part 11.

Understand how comprehensive solutions for cell therapy quality control, including CAR/TCR detection, residual testing, and potency assays, ensure stability, multi-batch validation, and adherence to strict quality standards.

As healthcare advances, innovative solutions connect patients to personalized cell and gene therapies, supporting unique treatment journeys in a rapidly evolving industry.

Laboratories are increasingly adopting electronic records and signatures to enhance data management. Hone in on how this digital shift demands compliance with FDA regulations, such as 21 CFR Part 11, to ensure secure, traceable systems.

This Regulatory Operations Team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.

Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.