Global Regulatory Affairs
Regulatory Affairs remains 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
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Starting with product risk classification and considerations for regional requirements, we build a success plan for each product.
Communication​
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Depending on the approach, early alignment with authorities may be the best form of project risk mitigation. We will help with each step.
Labeling​
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We can help you solve common challenges arising from region-specific requirements, even as they impact packaging design or manufacturing.
Documentation​
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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.
Submissions​
Where to?
- FDA pathways
- EU
- UK
- LATAM
- Canada
- Australia
- ROW
