Delivering sound regulatory strategies and operational support for drug and device development.

Global and local regulatory insights

We continuously monitor today’s complex and ever-changing global regulatory landscape to efficiently deliver quality regulatory services and submissions.  By staying ahead of all current legislation, guidelines, and other regulatory intelligence, we can advise you across all aspects of the development process, including the maintenance of marketed products. Our global presence enables us to bring a deep understanding of local regulatory requirements to every project, keeping your research on time and on budget.

A full-service regulatory partner

  • Regulatory project management and submissions
  • Regulatory technology and information management
  • Labelling, including content development, project management, document review and compliance
  • Medical writing, quality control and editing services
  • Regulatory CMC to ensure practices are compliant with global requirements
  • Clinical trial transparency including complete trial disclosure lifecycle management

​Our full range of strategic and operational regulatory services include support for:

Customised solutions

The focus is always on designing a package of services to meet your organisation's needs and study requirements. Teams located in offices across the globe enable us to provide you with the right service, at the right time, according to your specific clinical development plan.

Our combined industry and CRO experience, in all phases of clinical development and commercialisation and in all major clinical indications, allows us to provide expert regulatory project management and consultancy services to meet your complex and evolving needs.