Highly experienced in instrumental methods of pharmaceutical analysis.
Expertise with formulated product, API and synthetic intermediates.
Management of stability studies according to ICH guidelines.
- Development of analytical strategies/programmes required to support CTA/IND through to marketing applications.
- Sound knowledge of regulatory requirements and the production of dossiers according to the CTD.
- Method development and validation according to ICH guidelines.
- Comprehensive skills in developing chromatographic separations. A special interest in solving solid state problems e.g. polymorphism.
Outsourcing, including bioanalytical programs.
- SOPs, specifications and working to GMP
- Extensive specialist experience in inhalation product testing and other novel devices.
- Recognised expert in high quality documentation.