Cell & Gene

Cell & Gene Therapy

Cell & Gene Therapy

Compliance Insight is a FDA compliance consulting firm that helps the biopharmaceutical industry navigate the regulatory and scientific challenges in cell and gene therapy product development and commercial production. We work with clients to define appropriate development strategies, identify potential pitfalls, and manage change within their organizations.

Compliance Insight then applies pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (CGT) field. Our FDA Compliance experts leverage our deep knowledge, extensive experience, and trusted relationships in the CGT world to provide exceptional service that helps accelerate innovation.

Compliance Insight is a FDA regulatory consulting firm committed to helping clients achieve their highest potential through world-class FDA Regulatory Affairs support services with subject matter experts on current and CGT products.

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

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