R&D / Formulation
Pharmaceutical formulation development support
Structuring an immediate-release tablet development so trial data leads to a scalable, documented formulation.
Illustrative use caseCapability
Product & Formulation Development
From prototype to a robust, scalable formulation: dosage-form design, optimisation and the process knowledge that makes a product manufacturable.
What we do
Formulation work succeeds when formulation, analytical and process decisions are made together. We structure development around critical quality attributes and use designed experiments to understand which variables matter before scale-up.
Dosage forms listed below are areas we can discuss and scope. Specific capability for any product category is confirmed only after technical assessment and partner availability.
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
Tablets
Partner-coordinatedDirect compression, wet and dry granulation, coating; hardness, friability and dissolution targets.
Capsules
Partner-coordinatedPowder and pellet filling, fill-weight uniformity and shell selection.
Oral liquids
Partner-coordinatedSolutions and suspensions: preservative efficacy, taste masking, viscosity and redispersibility.
Topical formulations
Partner-coordinatedCreams, gels and ointments: rheology, release testing and container compatibility.
Sterile products
Partner-coordinatedParenteral formulation considerations, filtration, terminal sterilisation versus aseptic route.
Novel formulations
Partner-coordinatedModified release and enabling technologies, scoped case by case.
Generic product development
DGXP-ledReference product deformulation, Q1/Q2 assessment and comparative dissolution.
Product optimisation
DGXP-ledRoot-cause analysis of variability and targeted reformulation.
Process optimisation
DGXP-ledParameter studies, yield improvement and robustness evaluation.
Typical project types
Formulation optimisation
Reduce variability in dissolution or content uniformity through a structured DoE.
Process scale-up
Move from laboratory to pilot and exhibit scale with a documented rationale.
Analytical method development
Stability-indicating methods ready for validation at the receiving laboratory.
Technology transfer
A transfer package the manufacturing site can execute without re-discovery.
Formulation development path
- 1Target product profile
- 2Pre-formulation
- 3Prototype trials
- 4Optimisation (DoE)
- 5Analytical support
- 6Scale-up batch
- 7Development report
- 8Transfer
Technologies and processes
- Fluid bed processing
- High-shear granulation
- Roller compaction
- Tablet compression & coating
- Encapsulation
- Design of Experiments
- Comparative dissolution (f2)
Example projects
Illustrative use cases showing how this capability is typically applied.
Manufacturing / R&D
Pharmaceutical process optimisation
Reducing yield loss and in-process rejections in an oral solid dosage process.
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 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.
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Frequently asked questions
Which dosage forms can you support?
We scope each request against partner capability. Oral solids are the most common starting point; other forms are assessed individually.
Do you use Quality by Design?
Yes. Development plans are built around critical quality attributes, risk assessment and designed experiments, in line with ICH Q8–Q10 principles.
Who owns the development data?
Ownership and confidentiality are agreed in the project contract before work begins.
Discuss a formulation development requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.