Pre-Formulation/ Process and Formulation Development
Our experienced and motivated team will support you from early development to industrial scale.
A dedicated project manager will lead a development team of experts nominated from our centres of excellence (dosage forms and analytical) providing tailor-made solutions to serve the specific needs of your development project.
The services include but are not limited to:
- Scientific and regulatory guidance on concept/strategy for formulation and process development
- Full characterisation / reverse engineering of related products (if required)
- API/Excipient compatibility studies
- Quality by design (QbD) based formulation and manufacturing process development tailored to individual project requirements
- Predefined objectives (Quality target product profile (QTPP), Critical Quality Attributes (CQA))
- Product and process understanding (gaps analysis, risk assessment, Critical material attributes (CMA), Critical process parameters (CPP))
- Process control (Control strategy)
- Analytical method development
- Stress stability testing