For startups and small companies preparing to engage a Contract Development and Manufacturing Organization (CDMO), the Request for Proposal (RFP) process is a critical early step. Yet, it’s often approached without sufficient input from Regulatory Affairs — leading to incomplete scopes, unclear expectations, and delayed timelines.
From the experience at Starodub BV, as a regulatory consultancy supporting development teams, it is clear that regulatory involvement at the RFP stage is not just helpful — it’s essential. Without regulatory guidance, proposals may overlook compliance requirements, lack clarity on filing expectations, or fail to reflect quality system needs. This can result in CDMOs submitting bids based on incorrect assumptions, which ultimately leads to scope changes, timeline disruptions, and additional costs.
Early regulatory input helps ensure:
- Regulatory strategy is reflected in the RFP
- Requirements for documentation, quality, and data integrity are clearly communicated
- CDMOs understand the intended markets and development stage
- Proposals are more accurate, realistic, and aligned with long-term goals
Startups often work with limited resources — but cutting corners on regulatory alignment at this stage can be far more costly in the long run. A well-prepared RFP, supported by regulatory expertise, lays the foundation for successful CDMO partnerships and smooth downstream execution.
Bringing regulatory into early discussions is not a luxury — it’s a smart investment.
If your team is preparing to select a CDMO and could benefit from regulatory support, our expert consultants are here to help. Reach out to explore how we can strengthen your RFP process and set your project on the right course from day one.
