What does a CDMO need to know to quote?
What the material is for, and how mature the process is. A batch for toxicology studies, Phase 1 supply and commercial supply carry different GMP expectations, scales and documentation. In the US, most Phase 1 investigational drugs are exempt from the full 21 CFR 211 rules but must still be made under appropriate current good manufacturing practice (FDA guidance, 2008). State the stage and the GMP status up front, with the scale, the modality and what the CDMO receives from you.
What goes in a technology transfer package?
WHO's guideline on technology transfer in pharmaceutical manufacturing (TRS 1044, Annex 4, 2022) covers gap analysis, quality risk management, documentation, qualification and validation, and analytical method transfer. In practice, a CDMO will ask for the process description and history, batch records, analytical methods and specifications, the raw material list and, for biologics, cell bank information. ICH Q5D covers the derivation and characterization of cell substrates.
Share it under a confidentiality agreement, and agree in the contract who owns process improvements made at the CDMO.
Which GMP guidelines apply?
ICH Q7 sets GMP for active pharmaceutical ingredients. Sterile products made for the EU follow EU GMP Annex 1, revised in 2022 and fully applicable since August 2024. Name the regions the material must be acceptable to, so the CDMO quotes against the right expectations. A regulatory expert should confirm what applies to your product.
From brief to quotes
Copy or print the brief and send it under a confidentiality agreement, or compare quotes from vetted CDMOs on BioBridgeX. For context on how CDMOs differ from CROs, read what a CDMO is, and for budgeting, the GMP manufacturing cost guide.
Frequently asked questions
What should a CDMO RFP include?
The product and modality, stage and intended use of the material, the services needed, current process status and material in hand, scale and number of batches, analytical and GMP requirements, timeline, location, and how you will evaluate responses. The planner builds this as a brief.
How do you choose a CDMO?
Match capability to modality and scale, check quality history and regulatory inspection record, confirm capacity for your timeline, and compare how each prices fixed work, estimates and pass-through costs. Ask for references in your modality.
What is a tech transfer package?
The documents and data a receiving site needs to run your process: process description and history, batch records, analytical methods and specifications, raw materials and, for biologics, cell bank information. WHO TRS 1044 Annex 4 describes the technology transfer process.
Does Phase 1 material need full GMP?
In the US, most Phase 1 investigational drugs are exempt from the full 21 CFR 211 regulations but must be made under appropriate CGMP, as FDA's 2008 guidance explains. Other regions differ, so confirm with a regulatory expert.
Should a CDMO brief be sent under a confidentiality agreement?
Yes, before sharing process details. A short brief describing scope can go first; the technology transfer package follows under the agreement.
Is anything I type stored or shared?
No. The planner runs entirely in your browser. Nothing you enter is saved, sent to BioBridgeX, put in the page address or passed to analytics or AI services. Closing or refreshing the page clears it, so copy or print the plan before you leave.
Is the generated plan a protocol?
No. It organizes the requirements you entered into a structured outline and lists what is still undecided. It is not a validated protocol, it does not recommend sample sizes, and it does not establish GLP, GMP or regulatory compliance. Have the plan reviewed by qualified scientific, statistical, ethical and regulatory experts.
Related free tools
- GLP Toxicology Study Checklist: Modality, route, species, duration, milestone, material and questions for the CRO as a planning checklist.
- Bioanalytical Study Planner: Analyte, matrix, species, sample count, concentration range, method and validation needs as a project brief.
- All study planners and every free tool on BioBridgeX.
Sources
- FDA guidance: Current Good Manufacturing Practice for Phase 1 Investigational Drugs (2008)
- WHO guidelines on technology transfer in pharmaceutical manufacturing, TRS 1044 Annex 4 (2022)
- ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients
- ICH Q5D: Derivation and characterisation of cell substrates
- EU GMP Annex 1: Manufacture of sterile medicinal products (2022)
This planner organizes requirements. It is not a validated protocol, does not recommend sample sizes, and does not establish GLP, GMP or regulatory compliance. Review every plan with qualified scientific, statistical, ethical and regulatory experts. Facts on this page last checked 27 October 2026.
Compare quotes from vetted Process Development suppliers on BioBridgeX. Free for buyers. Planning is optional: these tools work without an account, and nothing you enter is shared.