R&D / Formulation
Pharmaceutical formulation development support
Structuring an immediate-release tablet development so trial data leads to a scalable, documented formulation.
Illustrative use caseCase library
Projects & use cases
How pharmaceutical requirements become executed, documented and verified work. Each example sets out the challenge, requirement, approach, process, technology, documentation, verification and expected outcome.
All projects on this page are illustrative use cases. They describe typical project structures and do not disclose client names, products or results.
Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use case
CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use case
CDMO / R&D
CDMO product development coordination
Coordinating formulation, analytical and scale-up work across a CDMO and a separate testing laboratory.
Illustrative use case
Laboratory / Quality
Contract laboratory testing programme
Setting up release and stability testing at a contract laboratory for a new product.
Illustrative use case
Manufacturing / R&D
Pharmaceutical process optimisation
Reducing yield loss and in-process rejections in an oral solid dosage process.
Illustrative use case
Automation / Quality
PLC / HMI / SCADA design & verification
Specifying and verifying the control system of a new filling machine before GMP use.
Illustrative use caseDigital / Manufacturing / Software
Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
Illustrative use case
Software / Quality / Digital
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Illustrative use caseQuality / Digital / Software
eQMS workflow digitisation
Moving deviation, CAPA and change control from paper forms to linked electronic workflows.
Illustrative use case
AI / Quality / Training
AI-based SOP knowledge assistant
An assistant that answers procedural questions from effective SOPs, with citations.
Illustrative use case
AI / Regulatory
AI regulatory document intelligence
Using AI to locate, compare and summarise content across regulatory documents.
Illustrative use case
AI / Quality / Manufacturing
AI deviation investigation support
Surfacing similar past deviations and likely contributing factors to support investigators.
Illustrative use caseAI / Quality
AI quality risk assessment
Classifying proposed AI use cases by risk and defining the validation each one needs.
Illustrative use case
AI / Quality / Software
AI validation framework
A validation approach for AI-enabled GxP applications, from intended use to monitoring.
Illustrative use caseTraining / Software / Digital
Pharmaceutical training management platform
Course, module, assessment and certificate management linked to controlled documents.
Illustrative use caseLaboratory / Digital
Digital laboratory workflow
Replacing paper sample logs and result sheets with a barcode-driven laboratory workflow.
Illustrative use case
Digital / AI / Laboratory
Pharmaceutical data intelligence
Bringing batch, laboratory and quality data together for trending and product review.
Illustrative use case
Regulatory / Manufacturing / Quality
Technology transfer documentation
Building a complete documentation set for transferring a product between sites.
Illustrative use caseDigital / AI / Automation
Pharmaceutical lifecycle digitalisation roadmap
A phased roadmap connecting laboratory, manufacturing and quality systems, with AI where it fits.
Illustrative use caseNo projects match. Clear the search or choose another category.
Illustrative example: external manufacturing project
A pharmaceutical organisation requires an external manufacturing partner for a product.
- 1
Requirement understanding
Understand product, dosage form, scale, technical and market requirements.
- 2
Technical assessment
Identify manufacturing and technical requirements.
- 3
Partner identification
Identify suitable CMO/CDMO capabilities.
- 4
Evaluation
Assess technical, quality, regulatory and operational suitability.
- 5
Technology transfer
Transfer appropriate product and process information.
- 6
Manufacturing
Manufacturing is performed by the selected qualified organisation.
- 7
Testing & documentation
Applicable testing, quality documentation and review are completed.
- 8
Project coordination
DGXPComplianceLab coordinates activities and stakeholders according to the agreed scope.
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