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 SeptemberLocation: Madrid, Spain
Nordic Life Science DaysNordic Life Science Days annual conference will be attended by Nathalie Huther, Business Development Manager Europe.
Nordic Life Science DaysDates: 10th - 12th SeptemberLocation: Stockholm, Sweden
PHSS & UCL Q3P Annual ConferencePHSS & UCL Q3P Annual Conference will be attended by Angela Fuller, Microbology Team Leader.
PHSS & UCL Q3P Annual ConferenceDates: 11th SeptemberLocation: UCL, London