To fullfill ICH Q3D requirements before deadlines expired, we develop Elemental Impurities Implementation of Risk Assessment Reports, for both API manufacturers and drug product manufacturers.

We design and develop tailored made action plans to implement this guideline:

We offer full support risk assessments of elemental impurities for all the products required.

In case of a large catalog of products, the development of the reports is made according a priorization plan.

Our experience with more than 1,000 reports developed in different kind of products (under development, finished product) and routes of administration gave us a general vision to find the best solution.

You can contact us regarding a QUOTATION REQUEST  for an ICH Q3D report development.