Key Skills

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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.

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