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