Don’t Reach Out Yet: 10 Internal Questions to Answer First

When you’re eager to keep development moving, it’s tempting to send out RFIs as soon as a timeline, budget, or scope starts to form. But if you haven’t had the tough internal conversations yet, early CDMO outreach can actually slow things down, or worse, attract the wrong partner entirely.

Before any outreach begins, there are critical alignment points your team needs to work through. Not just with the CMC lead, but across regulatory, clinical, finance, and leadership.

Here are ten internal questions to answer before you ever hit send on that email:

1. What phase are we targeting and what’s locked vs. still in motion?

Many sponsors reach out saying “we’re preparing for Phase 1,” only to clarify later that the tox package isn’t final, or the timeline depends on fundraising. CDMOs need a clear view of your development context to scope realistically.

2. Do we need development support, manufacturing only, or both?

Clarify whether you’re looking for formulation development, process optimization, method validation, or just GMP execution. These differences impact pricing, timelines, and even which CDMOs are qualified to support you.

3. Have we defined our must-haves vs. nice-to-haves?

If you ask for isolators, tech transfer before Q4, and U.S. only, but don’t rank what really matters, you risk filtering out CDMOs who could’ve been the right fit. Internal prioritization leads to better external options.

4. Is our batch size driven by science, regulatory strategy, or budget?

Your answer changes the CDMO’s recommendation. Be clear on what’s driving your batch size so they don’t design a scope that mismatches your risk tolerance or needs.

5. What is our internal timeline, and what’s driving it?

Timelines often slip internally before they ever slip externally. Be honest about what’s tied to board pressure vs. actual trial start. You’ll save yourself the pain of compressed schedules and change orders later.

6. Who will review the proposal and who makes the final decision?

The CDMO will tailor their proposal differently for a scientist-led decision versus a CEO-led one. Get alignment now so you’re not re-requesting a rephrased version a week before your MSA is due.

7. Have we reviewed our own data and gaps?

Make sure you know what you’re transferring: what methods are validated, what assays need bridging, and whether any previous data will require rework. CDMOs can’t quote confidently on uncertainty.

8. Who is responsible for tech transfer, oversight, and CMC project leadership?

If your internal bandwidth is light, a CDMO with strong PM support might be more important than one with the fastest lead time. Match their services to your team’s reality.

9. Have we involved Quality and Regulatory early?

If they’re not looped in until after the proposal is signed, you risk derailing timelines or renegotiating scope. CDMOs appreciate knowing QA and RA won’t be afterthoughts.

10. Are we prepared to move forward if the right partner responds?

If the answer is no because of budget, team bandwidth, or internal decision-making, it’s better to delay outreach. CDMOs can tell when a sponsor isn’t ready. And they’ll deprioritize accordingly.

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CDMO business development teams don’t expect every answer to be perfect. But what we value, what helps us respond faster and better, is clarity and alignment across your team.

Want a more structured way to get internal alignment before reaching out? Check out my course: “How to Get Internal Alignment Before Engaging a CDMO”. It includes frameworks and checklists to help biotech sponsors avoid costly missteps and get better proposals from day one.

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For more insights and personalized support in navigating the biotech-CDMO landscape, visit my website: www.yourpharmagirl.com and follow Your Pharma Girl on LinkedIn. Whether you need strategic guidance, tailored BD solutions, or expert advice on building lasting partnerships, I'm here to help you and your team succeed at every stage of development.