Thirteen stages
The pharmaceutical lifecycle
From discovery to AI-supported continuous improvement: what happens at each stage, the typical activities, and which DGXPComplianceLab capability supports it.
Interactive lifecycle
Select a stage. Use the arrow keys to move between stages.
Stage 1 of 13
Discovery
Identifying a therapeutic need, target or product opportunity, and deciding whether it is worth developing.
- Opportunity and literature assessment
- Reference product and patent landscape
- Target product profile (first draft)
Stage 2 of 13
Research
Building the scientific understanding of the molecule and the product concept.
- API characterisation
- Pre-formulation studies
- Feasibility experiments
Stage 3 of 13
Formulation Development
Designing a dosage form that delivers the drug reliably and can be manufactured consistently.
- Prototype formulations
- Excipient selection
- Optimisation using DoE
Stage 4 of 13
Analytical Development
Developing and validating the methods that prove identity, strength, purity and performance.
- Method development
- Method validation (ICH Q2)
- Specification setting
Stage 5 of 13
Process Development
Understanding the process well enough to scale it and control it.
- Critical process parameters
- Scale-up studies
- Process risk assessment
Stage 6 of 13
Clinical / CRO
Generating the study evidence a product needs, through contract research organisations.
- Study scoping
- CRO coordination
- Data and report review
Stage 7 of 13
Technology Transfer
Moving product and process knowledge to the site that will manufacture it.
- Transfer protocol
- Knowledge package
- Exhibit / validation batches
Stage 8 of 13
Manufacturing
Producing batches consistently under GMP at a qualified site.
- CMO / CDMO manufacturing
- Process validation
- Batch record review
Stage 9 of 13
Quality & Compliance
Making sure every batch, record and system meets the required standard.
- Deviation and CAPA
- Change control
- Computerised system validation
Stage 10 of 13
Regulatory
Preparing and maintaining the information regulators need to approve and oversee a product.
- CMC documentation inputs
- Change impact assessment
- Inspection readiness
Stage 11 of 13
Commercialisation
Supplying the market reliably: packaging, release, distribution and lifecycle management.
- Packaging and serialisation
- Supply continuity
- Annual product review
Stage 12 of 13
Digital Transformation
Replacing paper and disconnected tools with controlled digital workflows.
- eQMS, LIMS, DMS, LMS
- Electronic batch records
- Digital validation
Stage 13 of 13
AI & Continuous Improvement
Using data and AI — under governance — to learn from every batch, test and document.
- AI use cases
- AI governance and validation
- Performance monitoring
Capabilities mapped to the lifecycle
Where each capability typically contributes. A filled cell means the capability is commonly involved at that stage.
| Capability | Discovery | Research | Formulation Development | Analytical Development | Process Development | Clinical / CRO | Technology Transfer | Manufacturing | Quality & Compliance | Regulatory | Commercialisation | Digital Transformation | AI & Continuous Improvement |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Research & Development | — | Yes | Yes | Yes | Yes | — | Yes | — | — | — | — | — | — |
| Formulation Development | — | — | Yes | Yes | Yes | — | Yes | — | — | — | — | — | — |
| External Manufacturing | — | — | — | — | — | — | Yes | Yes | Yes | — | Yes | — | — |
| CMO / CDMO | — | — | Yes | — | Yes | — | Yes | Yes | Yes | — | — | — | — |
| CRO | — | Yes | — | Yes | — | Yes | — | — | — | Yes | — | — | — |
| Contract Laboratory | — | — | — | Yes | — | — | — | Yes | Yes | — | — | — | — |
| Technology & Engineering | — | — | — | — | Yes | — | — | Yes | Yes | — | — | Yes | — |
| Digital Transformation | — | — | — | — | — | — | — | Yes | Yes | — | — | Yes | Yes |
| Pharmaceutical Software | — | — | — | — | — | — | — | — | Yes | Yes | — | Yes | Yes |
| AI for Pharma | — | Yes | — | — | — | — | — | Yes | Yes | Yes | — | — | Yes |
| AI Governance & Validation | — | — | — | — | — | — | — | — | Yes | Yes | — | — | Yes |
| Regulatory & Quality | — | — | — | — | — | — | — | Yes | Yes | Yes | — | Yes | — |
Why the lifecycle view matters
Most problems found late — a method that does not transfer, a process that will not scale, a record that fails an audit — started as a decision made earlier without the next stage in mind. Planning each stage against the whole lifecycle reduces that rework.
It is also how digital transformation and AI become practical: data that is structured and trustworthy at each stage can later be trended, connected and used to support decisions.
Lifecycle at a glance
- 1Discovery
- 2Research
- 3Formulation Development
- 4Analytical Development
- 5Process Development
- 6Clinical / CRO
- 7Technology Transfer
- 8Manufacturing
- 9Quality & Compliance
- 10Regulatory
- 11Commercialisation
- 12Digital Transformation
- 13AI & Continuous Improvement
Have a research, manufacturing, technology or digital requirement?
Tell us what you need. We will discuss scope, the capabilities involved and how the project could be executed.