Technology Transfer

A pharmaceutical client engaged Concuir to support a technology transfer of a solid oral dosage product from one contract manufacturer to another. The transfer required coordination across multiple teams, vendors, and geographies while ensuring analytical methods were successfully transferred and validated at the receiving site.

During the process, the receiving CDMO encountered challenges with analytical method confirmation, leading to delays in method qualification that impacted the overall project timeline. Concuir consultants stepped in to assess the issue, identify root causes, and facilitate communication between the sending and receiving analytical teams.

Through structured project management and technical oversight, Concuir ensured alignment on analytical parameters and developed a corrective action plan to harmonize analytical methods between sites. We coordinated with both manufacturing partners to execute re-testing, data review, and documentation updates, ensuring minimal impact to the project timeline and budget.

• Centralized coordination between internal teams, partners, and vendors
• Clear governance and communication structures to keep all stakeholders aligned
• Technical document authoring and review (i.e., methods, batch records, etc.)
• Risk-managed execution with proactive issue identification and mitigation
• Confidence in domestic and global transfers involving multiple sites, organizations, and logistics
• On-time and on-budget execution with transparency and leadership visibility

The result was a successful transfer with validated methods, enabling uninterrupted manufacturing and keeping the client’s manufacturing schedule on track.