Acrux has a vast array of experience in generic and innovative product development
- Formulation development using QbD approaches.
- Analytical method development and validation (AQbD).
- Bioequivalence & characterisation studies (as required).
- Regulatory strategy, dossier preparation and submissions.
- Indicative stability studies & QC testing.
- Technology transfer of analytical methods and manufacturing process.
- Specifications and justification of specification.
- Preparation of Pharmaceutical Development report.
- API sourcing and selection.
- Container closure system sourcing and selection.
- Experience with sterile and non-sterile dosage forms.