Drug Development Expertise and Support
With over 20 years as part of one of the top 5 global pharmaceutical companies, combined with 5 years working for one of the world’s largest CROs, the Arcinova team have a unique insight into your needs.
Our experts can work individually, collectively or as part of your development project team to assess the data from your compound and recommend a path forward to achieve rapid drug registration, solve ongoing problems or carry out due-diligence.
Whether you require expertise or advice in a particular area or a more integrated, holistic approach, we are here to help.
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Prior to approving any clinical trial, the relevant global regulatory agency needs to be assured that the chemistry, manufacturing and control elements have been appropriately considered and documented.
Potential Mutagenic Impurity (GTI) Assessments
Arcinova have the expertise necessary to assess the mutagenic potential of impurities and degradation products required for successful regulatory submissions.