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The life sciences industry is confronting a wave of transformational change, brought about by multiple factors, including the growth of new clinical trial markets, a rapid rise in drug development innovation, reimbursement challenges, heightened regulatory requirements and a demand for evidence-based medicine, among many others. These drivers and the resultant changes are having a profound effect on regulatory affairs.

Regulatory affairs departments are accustomed – and even open — to change and adapting their technology and processes in response…

If you’re in Regulatory Affairs, you know the IDMP-compliance-truck is headed your way. Which questions though are plaguing your team?…

Every one of us at some point will take a medication and likely suffer some sort of adverse reaction. However,…

What are the Challenges in the Pharma Industry Regarding Data Privacy? Data privacy and data retention seem to become more…

A preview of DIA’s upcoming Regulatory Conference, where ArisGlobal will unveil its revolutionary regulatory information management system software. It’s no secret, the…

Keeping track of all the information required to manage your medical devices on the market is a hugely complex task,…

By Danilo Pavlovic As both a conference attendee and ArisGlobal representative…

As the outsourcing trend continues to grow, many biopharmaceutical and pharmaceutical companies find themselves needing to partner with CROs (contract…

With declining R&D budgets, increased competition from larger CROs and patent expirations, emerging CROs have evolved from being non-core service…