Consultancy

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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CMC Dossiers

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.

 

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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.

 

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