Your Team,
Extended.
An End-to-End Extension of Your Team
We are a science-driven consulting boutique that provides comprehensive services from non-clinical to CMC for CGT and biologics developers and CDMOs, with a focus on
rare and ultra-rare disease programs.
CMC Consulting
Whether you are developing a viral vector, a complex biologic, or a gene-modified cell therapy, you may not have a “platform process” to adopt. TKD Solutions brings decades of CMC expertise to help you perform high-quality pilot non-GMP runs that are process-representative to efficiently identify Critical Process Attributes and Critical Quality Attributes, laying the CMC foundation for your novel therapy.
Regulatory Expertise
From accelerated approvals to plausible mechanism pathways, TKD Solutions is immersed in the latest regulatory approaches to help bring treatments to patients in need – quickly. We bring this expertise to academic groups, foundations, and preclinical stage companies to give them the best opportunity to bring their treatments forward in a timely manner.
Our Inspiration
Over 8000 genetic rare diseases have been identified globally, yet the current therapeutic landscape indicates that only 5% of these conditions currently have FDA-approved treatments.
TKD Solutions aims to bring forth opportunities for true collaboration across development, supply chain, CMC, and regulatory pathways to develop risk-appropriate solutions that will rein in costs, reduce development timelines, and establish more robust platform approaches that are specifically designed for ultra-rare disease programs.
Ready to find the solution to get your product to the people who need it most?
Focus on what you do best and we’ll do the rest.