Regulatory Operations

Regulatory Operations are key areas of focus for lifesciences organizations since maintenance of compliance for marketed products as well as operational management of development products are key for success of programs. Often our clients seek expertise in regulatory operation functions since to access additional expertise or bandwidth. 

Artixio brings maturity in managing regulatory operations based on its industry experience of over 10 years in managing small to large scale regulatory operations programs for companies of different size. 

Artixio's management is among pioneers in centralizing global regulatory operations. Driven by technology enabled, KPI driven processes, Artixio provides high quality operations support ensuring compliance. 

Our Regulatory Operations Services Include: 

  • Regulatory Publishing and Submissions 

  • Matured Products Lifecycle Management 

  • Product License Renewals 

  • Annual Product Quality and Product Quality Reports 

  • Line Extensions 

  • Labeling Operations Management 

  • Artwork and Label Change Management 

  • Artwork and Label Proof Reading and Quality Check

  • Regulatory Data / Information Management 

  • Document Management Support