Research and Development​

HAS Healthcare Advanced Synthesis offers clients a full range of research and development services to successfully achieve chemical/analytical reproducibility.

  • Process development and/or optimization
  • Range finding studies according to classical and/or enhanced approaches (OFAT and/or DOE) to identify Critical Quality Attributes (CQA) as per Q11
  • Safety risk analysis to guarantee a robust and safe process before scaling up at industrial scale
  • Impurity identification according to cutting edge analytical equipment (NMR and MS), synthesis, full characterization, and supply
  • Impurity fate and purge studies to assess suitable specifications
  • Analytical method development and/or optimization
  • Analytical method conditions based on an enhanced approach (QbD)

In addition, our team’s proven experience will assist throughout the entire product lifecycle

  • Discussion of regulatory starting material strategy based on authority requirements
  • Full risk assessment before process validation execution (FMEA)
  • Validation master plans
  • Stability protocol for collecting data to assign a retest period that will be included in the regulatory filings
  • Preparation of various risk assessments for regulatory purposes (e.g. Elemental impurities, Nitrosamines)
  • Drug Master File (DMF) preparation, filing, and management upon request; or support in the preparation of the relative drug substance sections (3.2.S) for worldwide registrations
  • Regulatory assistance during the entire lifecycle of the project