Quality & Compliance
Quality built into every development decision
Quality by Design, documented processes and analytical evaluation connect formulation development with controlled manufacturing and continual improvement.
Quality by Design
A development approach that considers material attributes, process parameters and product quality together, with the assessment scope defined for each programme.
Controlled manufacturing
Documented processes and controlled manufacturing conditions support reproducibility as a formulation progresses towards commercial supply.
Analytical evaluation
Product characterisation, dissolution evaluation and stability assessment inform formulation and process development.
Continual improvement
Process understanding and analytical evaluation support an ongoing focus on robustness, scalability and manufacturability.
Quality through understanding
Understand the material. Control the process.
Technical assessment
The characteristics that shape product performance
The assessment plan is tailored to each formulation. Depending on the product, it may cover the following areas.
Material & particle attributes
- Particle-size distribution
- Drug loading and content uniformity
- Pellet morphology and mechanical properties
Coating & product performance
- Coating uniformity
- Dissolution behaviour and release characteristics
- Stability assessment
Process understanding
- Critical material attributes (CMAs)
- Critical process parameters (CPPs)
- Critical quality attributes (CQAs)
- Process robustness and manufacturability
Specifications, test methods and acceptance criteria are agreed for each product programme.
Regulatory support
Documentation for regulated markets
Dossier preparation and analytical documentation to support market-specific regulatory requirements.
- 01
CTD dossiers
Common Technical Document format prepared to specific country requirements.
- 02
DMF support
Drug Master File support underpinned by analytical development and validation.
- 03
Stability studies
Stability programmes to characterise products over their shelf life.
Partner documentation
Certifications & audits
Discuss facility documentation, audit planning and certification requirements with our quality team. Technical documents are shared under appropriate confidentiality.
Ask our team which certification, approval and registration documents are available for your product and market.