Delivering Training Solutions for Pharmaceutical Analysis
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Useful Links

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The following useful links are to websites which relate to pharmaceutical analysis.

Regulatory:

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

ICH is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The guidelines on Quality topics are most relevant to those working in the area of pharmaceutical analysis. These include guidance on: analytical method validation; test procedures which should be included in specifications; stability testing; and impurities among others.

Consultants:

 

 

ABPharm

ABPharm is a consultancy in Pharmaceutical Analysis and CMC, founded by Dr Alan Banyard and specialising in Analytical Development, Quality and preparing for Regulatory Submissions. ABPharm expertise includes analytical methodology, validation, drug characterisation, release testing and stability testing. They have a broad experience of development of API and a comprehensive variety of formulations and devices. ABPharma can assist in all CMC related activities; the objective is to support clients throughout the development of their product.

HPLC:

Shula Levin's  Homepage of HPLC and LC-MS

This website contains links to a range of resources intended for the academic support of HPLC/LC-MS users. A comprehensive collection of resources has been collected on the site.