Cell, Gene, and Tissue Therapies

Cell, gene, and tissue therapies offer unprecedented opportunities to both biotechnology companies and life-science investors. However, the road to commercialization for these therapies is largely unmapped. PharmaNet/i3 Consulting professionals provide expert guidance on predicting commercial feasibility, complying with GMP guidelines and evolving regulatory requirements, controlling biomaterial sources, and analyzing key issues in business opportunities.

PharmaNet/i3’s pharmaceutical and regulatory consulting team includes senior level expertise from the Office of Tissue, Cell/Gene Therapy (OTCGT). Our consulting services provide assistance with study design, regulatory strategy, Chemistry/Manufacturing Controls (CMC) issues, assessment of long-term risks, and interpreting actions and policies of worldwide regulatory agencies.