Global Regulatory Affairs

Regulatory Affairs is a cornerstone in Suma Medtec's portfolio of services. No matter the current regional focus of your product, we help prepare you to succeed while aiming for future growth.

Strategy: Starting with product risk classification and considerations for regional requirements, we build a success plan for each product.

Communication: Depending on the approach, early alignment with authorities may be the best form of project risk mitigation. We will help with each step.

Labeling​: We can help you solve common challenges arising from region-specific requirements, even as they impact packaging design or manufacturing.

Documentation​: We offer a new perspective to your Design History File documentation, identifying submission risks early in the process. Technical submission summaries are also a snap.

Registration services: Early project-specific strategies are established for each region, encompassing preparation of submissions, technical documentation, region-specific product labeling support, as well as product life-cycle management, change reporting, and renewals.

Submissions: FDA pathways, EU, UK, LATAM, Canada, Australia, ROW