Cell & Gene Therapy
Advancing complex biological therapies through precision execution and intelligent clinical design. We support the safe, scalable development of cell and gene therapies from early-phase exploration to global clinical delivery.
Cell & Gene Therapy
Advancing complex biological therapies through precision execution and intelligent clinical design. We support the safe, scalable development of cell and gene therapies from early-phase exploration to global clinical delivery.
Operational Excellence for the Most Complex Therapies
Cell and gene therapy programs demand a level of operational precision that goes far beyond traditional clinical development. These studies involve complex manufacturing pathways, evolving regulatory expectations, highly specific patient eligibility criteria, and tightly controlled handling logistics.
At unIQ Trials, we apply a highly personalized approach to every CGT program. We take time to understand the scientific mechanism, delivery platform, manufacturing constraints, and clinical objectives of your therapy before designing a tailored operational strategy.
Our teams guide sponsors through the full clinical journey – from early feasibility and first-in-human planning to global, late-phase delivery. We coordinate closely with vendors, sites, and regulators to ensure that every step of the process remains controlled, traceable, and inspection-ready.
Regulatory Strategy
Connecting your study to the right expertise, the right patients, and the right data.
Cell and gene therapy development comes with uniquely complex regulatory pathways. Advanced therapies often qualify for accelerated programs, but navigating these opportunities requires early planning, scientific rigor, and precise execution.
At UNIQ, we help sponsors build proactive regulatory strategies that align science, timelines, and agency expectations. We guide you in identifying and leveraging expedited pathways such as PRIME, Breakthrough Therapy, Fast Track, and Orphan Designations, while ensuring that early scientific advice and agency interactions are purposeful and strategically timed.
Our approach focuses on early engagement, clear positioning, and risk-aware planning, allowing sponsors to reduce uncertainty and avoid late-stage regulatory friction.
With experience supporting advanced therapy trials across North America, Europe, and Asia-Pacific, our regulatory specialists provide:
- Country-level regulatory intelligence and submission pathways
- Strategic advice based on precedent approvals and evolving guidance
- Proactive risk identification and mitigation planning
- Strong alignment between clinical design and regulatory expectations
We stay continuously connected to shifting global frameworks, enabling us to anticipate regulatory changes and keep your program positioned for success.
Beyond Data: Patient Dignity
We treat every participant as a pioneer. From informed consent design to post-infusion monitoring, our goal is to protect dignity while accelerating innovation.