Regulatory & Consultancy

Drug Development Expertise and Support

With more than 20 years as part of one of the top five global pharmaceutical companies, combined with 5 years working for one of the world’s largest CROs, the Arcinova team have a unique insight into drug development.

Our experts can work individually, collectively or as part of your team to assess data and recommend a path forward to achieve rapid drug registration, overcome problems or carry out due-diligence. Our agility and flexibility means we can embrace both small and large scale project challenges. 

Our customers benefit from close one to one support and direct contact with our scientists, and whether you require advice in a particular area or a more integrated, holistic approach, we can 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.



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.