Breakthrough Cancer Therapy

Compli is providing critical validation consulting services for a biopharmaceutical client developing a groundbreaking cancer therapy that leverages radioactive Lead-212. The drug, part of a joint venture with a major global pharmaceutical company, is set to enter Phase III clinical trials in September 2025. As the client prepares to scale clinical manufacturing and packaging operations at their Indiana facility, Compli is supporting key technical and regulatory readiness efforts to ensure project momentum and compliance.

Timeline: February 2025 – December 2025

Compli’s Role

Operating under the direction of the client’s Director of Global Engineering and Manufacturing, Compli’s validation consultant is responsible for leading daily execution activities to support project progress. These efforts include change control submissions, support for purchase requisitions, contract documentation, and facilitation of change control workflows within the client’s enterprise tracking system (ETS). The consultant also organizes signing parties and works to keep cross-functional stakeholders aligned with project goals.

Technical Services Provided

• Creation and tracking of parent records and child tasks within ETS
• Document review support for SOPs, training materials (OJTs/CBTs), batch records and material masters
• Coordination across Construction, Production, Supply Chain, Quality, Regulatory and Procurement teams
• Oversight of project activities and manpower assignments using a master Microsoft Project schedule

Project Impact

This project represents a significant step forward in the development of a novel cancer treatment. With Phase III trials on the horizon, Compli’s involvement is helping to ensure operational readiness, data integrity and regulatory alignment. By facilitating strong communication and coordination among internal teams, Compli is helping to lay the groundwork for the future commercial success of this life-changing treatment.