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delivering advanced expertise in

Cell & Gene Therapy

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FDA-Proven CGT Expertise: From Lab to Market

Our Chemistry, Manufacturing, and Controls (CMC), Nonclinical, and Clinical teams comprise former industry and FDA experts with decades of experience spanning development for various cell and gene therapy modalities. We use a team-based approach to support our clients’ programs from early-stage (nonclinical) development through clinical development, culminating in licensure and commercialization. We have extensive experience collaborating with companies worldwide to facilitate the regulatory process for their products' entry into the US market. Additionally, our expertise extends to litigation and due diligence support.

 

Technical Support

  • Process and analytical product development strategy
  • Process development and manufacturing support
  • Analytical method development, QC testing, and troubleshooting
  • Potency assurance strategy
  • Stability program strategy
  • Specification setting
  • Raw materials control strategy
  • Comparability strategy
  • Technical audits · Nonclinical program design (PD, PK, BD, Tox) and oversight
  • Nonclinical Study protocol and report review
  • Toxicological risk assessments, including novel excipients, impurities, and leachables
  • CRO selection and study monitoring · Due diligence
  • Clinical study protocol design and review

Regulatory Support

  • Gap assessments and remediations for regulatory submission
  • GMP systems and compliance support
  • GLP facility audits
  • Quality audits
  • FDA regulatory pathway strategies
  • Preparation and review of regulatory submission documents (PDUFA meetings, IND, BLA, DMF, special designations, etc.)

Quality Support

  • Process validation
  • Analytical method validation
  • QMS gap assessment and remediation
  • Quality assurance & compliance services
  • CDMO oversight
  • Preparation and review of Quality Agreements and Master Service Agreements