DRA expands operations in Europe

Dunn Regulatory Associates (“DRA”), a leader in Global Regulatory Consulting Services, is pleased to announce that it has expanded its operations into Europe. DRA EU will offer similar consulting services to the regulated life sciences industry in Europe as the US branch does, and will expand DRA’s capabilities with a presence in the EU. DRA EU is committed to providing clients with a greater level of local support and expertise for their regulatory challenges, applications and interactions with the EMA and MHRA.

We are pleased to present DRA EU’s Vice President of Medical Devices and Senior Consultant, Ajrula Zuta, an expert regulatory strategist with over 24 years of medical device industry experience collaborating with small, medium, and big sized companies on early and late stages in the product life cycle. Specializing in a broad range of services, his role within the DRA group focuses on the following device specific areas:

  • Global regulatory strategy and Compliance Planning
  • ISO 13485 QMS auditing
  • Development of Global Medical Device applications (e.g., USA, Canada, EU, Malaysia, Thailand, Korea, Japan, Australia, Singapore, Saudi Arabia, Brazil, etc.)
  • ISO 13485 QMS implementation
  • Gap analysis and development of medical device applications or QMS processes
  • US and EU agency/notified body interactions
  • Post-production agency interactions (e.g., post market surveillance, medical device reporting and field safety actions)
  • Regulatory advice and training
  • EU MDR support
  • Clinical evaluation reviews