Regulis signs agreement with ArisGlobal

We are always looking for ways to improve services to our clients and we are therefore delighted to share some exciting news!  We have engaged a new Safety Database Provider; we will be working together with ArisGlobal

What is ArisGlobal?

It is a prestigious Safety Database Provider fully E2B(R3) compliant with regulations from ICH, FDA, EMA and PMDA, including all regional variations.

ArisGlobal has 30-plus years of safety experience and it is used by 35 of the top 50 global pharmaceutical organisations. Also, it is fully compliant with GDPR.

ArisGlobal certifications includes:

  • ISO 9001:2015 Quality Management Systems requirements
  • ISO 27001:2013 Information Security Management System requirements
  • CMMI – Level 3 Appraisal Framework for Standardisation and Institutionalisation of Process
  • SOC2 Type II Assessment.

ArisGlobal is a fully validated system, that uses a pre-validation approach on a hosted platform.

Why are we changing to a new safety database?

Whilst our current database meets all the necessary standards and requirements, ArisGlobal will provide a number of improvements and benefits to our clients including:

  • Agility to ensure compliance with continually evolving regulations
  • Improved functionality to support continuous regulatory reporting compliance in the most cost-effective manner possible
  • Streamline procedures at Regulis.

If you would like to discuss your requirements for pharmacovigilance support, please don’t hesitate to contact one of the PV team.