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