Syner-G Brings a New Radiopharmaceutical Facility Toward GMP Operational Readiness

A radiopharmaceutical manufacturer was preparing to launch a new production facility while navigating concurrent construction, commissioning, qualification, and validation activities along with SOP development. The site needed to meet cGMP requirements, including 21 CFR Part 211 and USP <797>/<825>, while maintaining readiness for regulatory inspection. Mid-project, the facility’s scope shifted from commercial manufacturing to Phase I/II clinical production, introducing new operational, regulatory, and staffing requirements.

Syner-G embedded a cross-functional operational readiness team to provide both program leadership and hands-on execution across engineering, quality, manufacturing, automation, and validation. As the facility’s scope transitioned from commercial manufacturing to Phase I/II clinical production, Syner-G rapidly adapted the readiness strategy to align regulatory, operational, and business objectives while maintaining project momentum.

Syner-G helped the client advance facility startup and GMP operational readiness while managing scope change, leadership transitions, and crossfunctional dependencies. The program reduced the risk of compliance gaps, documentation deficiencies, and startup delays, while supporting successful technology transfer and inspection readiness. What began as a single engagement expanded across multiple phases, reflecting the value of a coordinated approach to facility startup, operational readiness, and clinical manufacturing transition.

Facing facility startup, operational readiness, or technology transfer challenges?

Syner-G partners with biopharma manufacturers and CDMOs to provide the embedded expertise, program leadership, and technical execution needed to accelerate readiness, mitigate risk, and support successful regulatory and manufacturing outcomes. Learn how our Strategic Development and Delivery Partner™ model can help bring your next facility online with confidence.