Services Genotoxic and Carcinogenic Impurity Assessments

Have a pharmaceutical product that needs a formal genotoxic and carcinogenic impurity assessment to meet the requirements of ICH M7? The expert toxicologists at Affygility Solutions can assist your company.

Whether in the United States, Europe, the Middle East, or Asia the toxicology professionals at Affygility Solutions have the expertise to assist you in complying with the FDA and EMA requirements on Genotoxic and Carcinogenic Impurities.1

Why choose Affygility Solutions for your Genotoxic and Carcinogenic Assessments?

  • Expert toxicologists with advance degrees and board certification (DABT);
  • Decades of pharmaceutical and biotechnology industry specific expertise; and
  • Experience with working with pharmaceutical and biotechnology companies in over 40 countries.

  1. As contained in the: Guideline on the Limits of Genotoxic Impurities – (EMEA/CHMP/QWP/251344/2006); and Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (M7).

How can we help?

We can help you design and implement a potent compound safety program tailored to your organization's exact practices and needs. Contact us to find out the details.