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. inVentiv Health Clinical 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.

inVentiv Health Clinical'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.

Therapeutic Expertise Brochure