CDMO / R&D
CDMO product development coordination
Coordinating formulation, analytical and scale-up work across a CDMO and a separate testing laboratory.
Illustrative use caseCapability
CMO / CDMO Services
Contract manufacturing and contract development-and-manufacturing support, coordinated through qualified partner organisations.
What we do
A CMO manufactures a product that is already developed. A CDMO also develops the formulation and process before manufacturing it. Choosing between them depends on how mature your product and process knowledge are.
DGXPComplianceLab helps define the scope, identify suitable organisations, manage the development-to-manufacturing interface and keep the quality and regulatory documentation aligned throughout.
Where it fits in the pharmaceutical lifecycle
Typical activities
Each activity shows who performs it. We do not claim facilities we do not own.
DGXP-led Led by the DGXPComplianceLab team Partner-coordinated Performed by a qualified partner, coordinated by us
Scope definition
DGXP-ledDeciding whether the requirement is CMO or CDMO, and which stages are in scope.
Partner evaluation
DGXP-ledTechnical, quality and capacity evaluation of candidate organisations.
Development
Partner-coordinatedFormulation and process development at the CDMO.
Scale-up
Partner-coordinatedEngineering and exhibit batches, equipment equivalence assessment.
Technology transfer
DGXP-ledProtocol, knowledge package, gap assessment and transfer report.
Manufacturing
Partner-coordinatedClinical or commercial batches at the partner facility.
Analytical testing
Partner-coordinatedRelease and stability testing at partner laboratories.
Quality documentation
DGXP-ledQuality agreement, change control and deviation interfaces.
Regulatory support
DGXP-ledCMC documentation inputs and site-change considerations.
CMO, CDMO, CRO or contract laboratory?
The right model depends on how mature the product and process are, and what you need the partner to own.
| Question | CMO | CDMO | CRO | Contract laboratory |
|---|---|---|---|---|
| Main purpose | Manufacture an already-developed product | Develop the formulation/process, then manufacture | Run research and clinical studies | Perform analytical and microbiological testing |
| Typical input | Transfer package, master batch record, specifications | Target product profile, API, development targets | Study question, protocol requirements | Samples, methods, specifications |
| Typical output | Released batches, batch documentation | Development report, scaled process, batches | Study report, data sets | Test results, certificates of analysis |
| Key agreement | Quality agreement, supply agreement | Development + quality agreement | Clinical / study agreement | Testing quality agreement |
| Our role | Scope definition, partner evaluation, technology transfer, documentation and coordination — the partner performs the regulated operation. | |||
CMO / CDMO project lifecycle
- 1Development
- 2Scale-up
- 3Technology transfer
- 4Manufacturing
- 5Analytical testing
- 6Quality documentation
- 7Regulatory support
Technologies and processes
- Oral solid dosage trains
- Sterile / aseptic processing
- Lyophilisation
- Bioprocess equipment
- Process validation
- Cleaning validation
Example projects
Illustrative use cases showing how this capability is typically applied.
CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use case
Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use caseOur project execution model
Every engagement follows the same eight steps, scaled to the size and risk of the project.
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01
Understand
Understand business and technical requirements.
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02
Assess
Assess scientific, technical, regulatory and operational requirements.
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03
Design
Design the appropriate solution.
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04
Identify
Identify appropriate internal and external capabilities and partners.
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05
Execute
Coordinate and execute the project.
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06
Verify
Test, verify, qualify or validate where applicable.
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07
Document
Create technical, quality and regulatory documentation.
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08
Improve
Monitor, optimise and continuously improve.
Related services
External Manufacturing
Identifying, evaluating and coordinating qualified external manufacturers so your product is made where the technical, …
Formulation Development
From prototype to a robust, scalable formulation: dosage-form design, optimisation and the process knowledge that makes…
Regulatory & Quality
GxP compliance, validation and documentation practices that make pharmaceutical work traceable, reviewable and inspecti…
Frequently asked questions
CMO or CDMO — which do I need?
If you have a validated process and full technical documentation, a CMO is usually enough. If formulation or process still needs development or scale-up, look at a CDMO.
Can one project use several partners?
Yes. Development, manufacturing and testing may sit with different organisations; we coordinate the interfaces and documentation between them.
How are quality responsibilities defined?
Through a written quality agreement listing responsibilities for materials, manufacturing, testing, deviations, changes and release.
Discuss a cmo / cdmo requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.