REGULATORY AFFAIRS

Ensure your business meets all the industry standards and requirements.

Our Professionals are a group of global Regulatory Affairs (RA) specialists exclusively serving the medical device and IVD industry. Our specialists work with the regulatory bodies, coordinating the submission of regulatory documents, answering regulatory bodies follow up questions and providing insight on how to navigate the evolving regulatory landscape. Our consultants are located in a number of strategic markets so regardless of your situation, we can channel your regulatory issues within our network.

  • COFS, Product Registration
  • Licence Holder Management.
  • Reimbursement Consulting.
  • Adverse Event Reporting and Product Recalls.
  • Compliance Training.
  • Regulatory Pathway for Foreign Markets

Interested in working with us?

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