How to Build a Better CDMO RFI or RFP

RFI stands for request for information.

A CDMO RFI is usually used earlier in the sourcing process to determine whether a manufacturer appears capable and interested.

The sponsor may ask about:

• relevant capabilities
• facility options
• manufacturing scale
• equipment
• development services
• regulatory support
• timing
• capacity
• previous experience
• general project fit

The goal is typically not to negotiate final commercial terms.

It is to decide whether the CDMO belongs in the next stage of the process.

RFP stands for request for proposal.

An RFP usually goes further than an RFI.

The sponsor provides more detailed information about the project and asks the CDMO to propose how it would support the work.

A response may include:

• technical approach
• scope
• proposed facility
• development activities
• manufacturing plan
• timeline
• responsibilities
• assumptions
• deliverables
• pricing
• commercial terms

An RFP is often sent to a smaller group of CDMOs after initial screening.

The right format depends on how much the sponsor already knows and how far the sourcing process has progressed.

An RFI is useful when the sponsor is still trying to understand whether a CDMO is capable and relevant.

An RFP is more appropriate when the project is defined well enough for manufacturers to propose a meaningful scope, timeline, and commercial approach.

Some teams use both.

A practical sequence might be:

1. Initial CDMO search→
2. preliminary screening→
3. RFI→
4. shortlist→
5. RFP→
6. deeper diligence→
7. selection

Other sponsors may skip a formal RFI and move directly into discussions or proposals.

The process should fit the program rather than following a rigid procurement template.

A detailed RFP can require substantial work from both the sponsor and the CDMO.

If the sponsor sends it to every manufacturer found during the initial search, much of that effort may be wasted.

Before issuing an RFP, narrow the market.

Confirm that each manufacturer appears to have a plausible technical and operational fit.

This can include reviewing:

• modality
• required manufacturing capabilities
• facility relevance
• scale
• equipment
• regulatory requirements
• development stage
• timing
• support needs

The RFP should go to companies that have a reason to be on the shortlist.

A CDMO should be able to understand the project quickly.

The opening section of an RFI or RFP should explain what is being developed, where the program is in development, and what the sponsor is asking the CDMO to do.

Avoid forcing the manufacturer to piece the opportunity together from multiple attachments.

A concise project summary may include:

• modality
• product type
• development stage
• current manufacturing status
• requested services
• anticipated manufacturing scale
• expected project timing
• intended regulatory markets

At the initial sourcing stage, sponsors should avoid unnecessarily sharing confidential information.

Provide enough detail to evaluate fit without disclosing information that is not yet required.

One of the fastest ways to get incomparable proposals is to send an unclear scope.

The sponsor should identify which activities are expected from the CDMO.

For example:

• process development
• formulation development
• analytical development
• method validation
• technology transfer
• engineering batches
• GMP manufacturing
• fill finish
• stability testing
• packaging
• release testing
• regulatory support

The scope does not need to be perfect.

It does need to be clear enough that manufacturers are responding to approximately the same request.

A response from a large CDMO should not stop at the parent-company name.

Ask which manufacturing facility would actually perform the work.

This matters because facilities can differ in:

• capabilities
• equipment
• production scale
• regulatory history
• available services
• geography
• project focus

The relevant diligence target is often the facility, not the brand.

A manufacturer may market the required service broadly, but the RFI or RFP should test the specific capabilities needed by the program.

Questions should reflect the project.

For example:

• Does the proposed facility currently support this modality?
• Which parts of the requested scope would be performed internally?
• Are any activities outsourced?
• What manufacturing scale is available?
• What equipment would be used?
• What development work would be required before GMP manufacturing?
• What technology-transfer activities would the CDMO expect?

Generic questions produce generic answers.

The strongest RFIs and RFPs connect each question to a real program requirement.

Confirm that the proposed site can support the scale required by the project.

Sponsors may want to understand:

• current scale
• minimum practical scale
• maximum scale
• batch-size flexibility
• clinical-scale capability
• potential commercial scale
• expected scale-up strategy

Scale should be considered in context.

A facility that is ideal for early clinical supply may not be the best long-term commercial partner, and a large-scale manufacturing site may not be the most practical option for an early program.

Where equipment materially affects process fit, ask about it directly.

The sponsor may need to confirm:

• equipment type
• capacity
• configuration
• single-use vs. stainless systems
• fill line format
• containment capabilities
• lyophilization capability
• specific processing technology

The exact questions will vary by modality.

The point is to verify that broad capability claims translate into a practical manufacturing setup.

A CDMO that primarily supports commercial products may operate very differently from one focused on early-stage biotech programs.

Ask about experience relevant to the sponsor's current stage.

Useful questions can include:

• What stages of development does this facility commonly support?
• Does the team regularly work with first-in-human programs?
• What development support is typically provided before GMP manufacturing?
• How does the company manage rapidly evolving early-stage processes?
• What would be expected from the sponsor before project kickoff?

The purpose is not to demand a particular client profile.

It is to understand whether the operating model fits the sponsor.

Timing questions should be specific.

Rather than asking:

"Do you have capacity?"

ask what would need to happen for the project to start.

Useful questions may include:

• earliest realistic project kickoff
• expected technical-transfer timeline
• development timeline
• manufacturing slot timing
• analytical lead times
• material-release timeline
• dependencies that could delay the project

Capacity information can change quickly.

Treat it as something that must be confirmed directly with the manufacturer rather than a permanent attribute of the company.

Depending on the program, the sponsor may need the CDMO to support specific regulatory markets.

Questions can address experience with:

• US FDA requirements
• EU GMP
• other relevant regulatory markets
• clinical manufacturing
• commercial manufacturing
• inspection history
• quality systems
• documentation expectations

An RFI or RFP response is one source of information, not the final qualification decision.

Regulatory history can be relevant during supplier evaluation.

Sponsors may review FDA Form 483 information, warning letters, inspection history, or other available regulatory context.

The sponsor should understand the specific observations, facility, timing, response, and relevance to the proposed work.

PCN provides FDA 483 context as part of preliminary diligence so teams can identify questions that may deserve additional review.

The technical capability of a CDMO matters.

So does the team that will actually run the project.

Sponsors may want to understand:

• who will manage the program
• how technical decisions are made
• meeting cadence
• escalation pathways
• communication expectations
• sponsor responsibilities
• CDMO responsibilities
• change-control processes

Many manufacturing relationships become difficult because expectations around communication and ownership were never made explicit.

If the project requires technology transfer, define what success looks like.

Questions may include:

• What information does the CDMO require from the sponsor?
• What documentation is expected?
• Who owns transfer activities?
• What development or engineering work will occur before GMP manufacturing?
• How are process differences handled?
• What constitutes completion of the transfer?

Technology transfer can become one of the highest-risk parts of moving a program into a new manufacturing environment.

It deserves more than a line item in the proposal.

Price matters, but pricing without scope is difficult to compare.

When reviewing proposals, understand what is included and excluded.

Look for:

• development fees
• technology-transfer fees
• batch costs
• analytical costs
• raw materials
• testing
• storage
• stability
• project management
• cancellation terms
• change orders
• minimum commitments
• pass-through costs

Two proposals with very different prices may actually contain very different scopes.

A lower headline number is not necessarily a lower total project cost.

A good RFP structure helps every CDMO answer the same core questions.

That makes comparison easier.

For example:

This does not mean every response will look identical.

It means the differences will be easier to understand.

Sponsors sometimes try to answer every possible diligence question before the first conversation.

That can make the RFI unnecessarily long.

The first request should focus on whether the manufacturer appears worth advancing.

Detailed quality, legal, contractual, financial, and technical diligence can follow as confidence increases.

A shorter, well-targeted RFI is often more useful than a fifty-page questionnaire sent too early.

Early CDMO sourcing should not require a sponsor to disclose every technical detail.

Share enough information for the manufacturer to assess whether the opportunity is relevant.

More sensitive information can be introduced later under appropriate confidentiality arrangements.

This is particularly important for emerging biotech teams evaluating multiple manufacturing options.

PCN supports controlled sponsor disclosure during early sourcing so the sponsor can begin exploring manufacturing options without necessarily exposing company identity or other sensitive information immediately.

An RFI is not just a document.

It is a decision tool.

The responses should help the sponsor determine which manufacturers deserve:

• technical discussions
• additional diligence
• site evaluation
• proposal requests
• quality review
• formal qualification

If an RFI does not help narrow the shortlist, it may be asking the wrong questions.

An RFP should move beyond capability confirmation.

It should help the sponsor understand how the manufacturer proposes to execute.

The strongest responses make clear:

• where the work will happen
• what the CDMO will do
• what the sponsor must provide
• how the process will be transferred or developed
• how long the work is expected to take
• what assumptions the proposal depends on
• how much the proposed scope will cost

That gives the sponsor something concrete to compare.

Pharma Connect Navigator helps sponsors structure the earlier stages of CDMO sourcing before a formal RFI or RFP is issued.

Sponsors define their manufacturing requirements, identify potential CDMO companies and facilities, compare project fit, and conduct preliminary diligence.

PCN also allows sponsors to send structured introduction requests using project information already entered into the platform.

That can help manufacturers understand the opportunity before the sponsor invests time in a larger procurement process.

Once a smaller group of CDMOs has been identified, the sponsor can move into deeper technical discussions, RFIs, RFPs, quality review, and formal selection.

The goal is to avoid sending detailed procurement requests to manufacturers that were unlikely to fit the program in the first place.

A structured process may look like:

1. Define requirements→
2. Find CDMOs→
3. Compare fit→
4. Preliminary diligence→
5. Initial outreach→
6. RFI→
7. Shortlist→
8. RFP→
9. Verify→
10. Select

Not every project needs every step.

The useful principle is to increase the amount of information requested as confidence in the manufacturing partner increases.