Consulting & Regulatory Support

PCT can provide you with consulting and regulatory support services to help you reach your goals even if outsourcing your product development and manufacturing to PCT is not a viable option.

Our team of experienced cell therapy specialists works closely with our Clients to provide comprehensive scientific, technical, and regulatory support, along the entire spectrum of cell therapy development. We bring to our consultations years of actual product development and manufacturing experience, in a cGMP regulated environment, with commercialization milestones.

Our Consulting Services include:

Product and Process Development

  • Process development, optimization and scale-up
  • Product characterization, product potency and product stability assays
  • In-process and final product test method development
  • Product shipping validation

GTP/cGMP Manufacturing

  • Facility design, construction, validation, and operation
  • Quality systems development and implementation

Regulatory Services

  • Product development strategy
  • Master File development
  • Investigational New Drug (IND) applications
  • Pre-clinical study design
  • Chemistry, Manufacturing and Controls (CMC) development
  • Biologic License Applications (BLA)
  • Preparation/representation at regulatory meetings
  • Regulatory submissions, amendments, supplements, and reports

Business Development and Commercialization

  • Strategic development
  • Financial modeling
  • Project management
  • Technology evaluation and licensing opportunities
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