Industries We Serve

Leveraging decades of expertise in drug development and manufacturing, Sequoia is a strategic partner for pharmaceuticals, biologics, and cell and gene therapy companies to progress their development programs and ensure operational readiness for clinical trials, commercialization, and post-commercial sustainability.

Our Expertise

Our experienced team of industry experts supports clients across the value chain, encompassing strategy, program management, quality and compliance, supply chain, engineering, validation, GMP laboratory and manufacturing, and GMP facility operations. This holistic support model empowers pharmaceuticals, biologics, and cell and gene therapy companies to drive innovation and accelerate the introduction of new therapeutic products to the market.

Sequoia has expertise in navigating multiple U.S. and international requirements to assess, develop and ensure alignment to lifecycle standards, guidance, and regulatory compliant applications in the pharmaceuticals, biologics, and cell and gene therapy sectors.

Relevant regulations and guidance include but are not limited to:

  • 21 CFR 1271: Human Cells, Tissues, and Cellular and Tissue-based Products
  • 21 CFR 210/211: Current Good Manufacturing Practices
  • 21 CFR Part 11: Electronic Records; Electronic Signatures
  • ISO 13485: Quality Management Systems
  • ISO 9001: Quality Management Systems
  • ISO 14971: Risk Management
  • EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
  • ICH Q1A-Q1F: Stability | Bracketing and Matrixing | Forced Degradation
  • ICH Q2: Analytical Validation
  • ICH Q3A-Q3E: Impurities | Residual Solvents
  • ICH Q4A-Q4B: Pharmacopoeias
  • ICH Q5A-Q5E: Quality of Biotechnological
  • ICH Q6A-Q6B: Specifications
  • ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
  • ICH Q8: Pharmaceutical Development
  • ICH Q9: Quality Risk Management
  • ICH Q10: Pharmaceutical Quality System

Therapeutics Case Studies and Resources: