Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.
RFPs for early formulation development are different from tech transfers, clinical supplies, and other RFP strategies because the scope requirements need more flexibility to accommodate the unknowns of R&D.
In pharma outsourcing, RFP templates are a time-saving and efficient tool to initiate and control a bidding process. They allow sponsors to collect comparable proposals that create leverage for negotiation.
Proactive companies and professionals tasked with procuring CMO services for difficult-to-place projects must become advocates to overcome barriers with a strategized approach and compelling narrative.
Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.