Gabriela Marton, Regulatory Affairs Director and Quality Director at Arriello, highlights EU regulatory challenges and calls for policy changes and education to maximize the opportunity for biosimilars to enhance patient outcomes.

Updated guidelines from the European Medicines Agency for pharmaceuticals marketing authorisation holders offer new clarity on what they must do to maintain continuity of supply of UK-registered products in Europe once the Brexit transition period ends.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations. Arriello's Vanessa Fachada Oliveira writes for Pharmaceutical Technology

Streamlining Pharmacovigilance: Why the Inertia? via Pharmaceutical Executive and Arriello's Director of Drug Safety Peter Kohut analyse the findings of a survey on how life sciences companies are capitalizing on opportunities to transform workload and data quality management using the latest smart technology.

Local affiliates are arguably just as in need of outsourcing support as primary pharma locations. But drawing on such services should be frictionless, and involve close coordination with the vision and goals of HQ. Anna Lukyanova COO of Arriello, explores where biotech and pharma firms can go awry in their international service use, and offers tips on how to ease the transition for all.

Never previously at the forefront of technology innovation, the life sciences industry now accepts that it needs to transform its agility, responsiveness and cost-efficiency, and that advanced digital tools are likely to form an important part of that strategy. Advanced digital tools are certain to play a pivotal role in the redesign of labour-intensive regulatory processes, but there is a danger that AI's potential contribution is being over-hyped. Arriello's CEO Alan White warns that the key to ROI is in the application...

Automation technology will play a key role in transforming labour-intensive regulatory processes in life sciences, but is AI being oversold by business process delivery partners? Alan White, CEO of Arriello, warns that focused application is essential to delivering results.

Soaring merger & acquisition activity in life sciences threatens competition and reduces customer options, both to patients and to pharma and biotech firms seeking help with growing pharmacovigilance and regulatory filing requirements. Alan White of Arriello explains why it has never been more important to choose wisely.