Regulatory & Consultancy
Potential Mutagenic Impurity (GTI) Assessments
Impurities in drug substances and drug products typically arise from synthesis and/or are degradants. However, some impurities, which are highly reactive because of their structure, have the potential to interact with DNA.
A mutagenicity assessment must be performed for all confirmed impurity/degradant structures found during the scientific evaluation of investigational drug substances and products in order to comply with ICH M7 guidance. Arcinova has the capability to arrange these assessments using a range of different software tools.
CPhI WorldwideCPhI Worldwide will be attended by Nathalie Huther, Business Development Manager Europe. Nathalie will be located at the DIT stand: 9J40
CPhI WorldwideDates: 9th - 11th OctoberLocation: Madrid, Spain
CMAC Open DayThe CMAC Open Day event will be attended by Gareth Jenkins, Chief Scientific Officer.
CMAC Open DayDates: 25th - 26th OctoberLocation: Glasgow, UK
Organic Process Research & DevelopmentThe Organic Process R&D conference will be attended by Nathalie Huther, Business Development Manager Europe.
Organic Process Research & DevelopmentDates: 29th - 31st OctoberLocation: Milan, Italy