Cell & Gene Therapy

Compliance Insight provides cell and gene therapy consulting to help biopharmaceutical companies address regulatory, manufacturing, and quality challenges throughout product development and commercial production.

Our consultants support regulatory strategy, pre-IND meeting preparation, IND submissions, GMP manufacturing planning, and quality management systems. We help teams identify compliance gaps, prioritize risks, and develop practical plans suited to their product and stage of development.

Whether you need support for a specific regulatory milestone or ongoing quality guidance, we work alongside your team to strengthen documentation, address manufacturing challenges, and prepare for FDA interactions. Contact Compliance Insight to discuss your cell or gene therapy project.

Explore our Biologics & Cell and Gene Therapy insights for articles on manufacturing quality, regulatory submissions, and development planning.

We are uniquely positioned to help you with:

• Regulatory classification and assessment
• Gap analysis
• Develop a strategic GMP manufacturing plan that reduces complexity, time and risk
• Build a regulatory strategy to facilitate successful regulatory meetings (pre-IND)
• Post approval regulatory support
• Preclinical and clinical support
• Design GMP manufacturing facilities, including commission, qualification, and validation
• Develop effective and customized Quality Management Systems (QMS)
• Product characterization (identity, viability, potency, purity, viral safety)
• Complex mode of actions and challenges to develop relevant assays
  Process and analytical development/validation, comparability, cGMP alignment
• Authoring of regulatory submissions (pre-IND, IND, briefing packages, investigational and marketing applications)
• Investigation and CAPA implementation
  Supply Chain reliability
• Technical writing experience