NeoStem
420 Lexington Avenue
Suite 350
New York, New York 10170
Telephone: 1.212.584.4180

PCT Services: Consulting & Regulatory Support

PCT provides cell therapy clients with consulting and regulatory support services to help them reach their goals.

PCT’s team of experienced cell therapy specialists works closely with their clients to provide comprehensive scientific, technical, and regulatory support, along the entire spectrum of cell therapy development. They bring to their consultations years of actual product development and manufacturing experience, in a cGMP regulated environment, with commercialization milestones.

PCT’s Consulting Services

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
NeoStem - Cell Therapy Development - Manufacturing