Precision for Every Pivot.
Whether entering a new market or managing a supplier change, SOLENA isolates the regulatory impact instantly.
Market Entry: Survive the 'One Strike' Standard.
In markets like Brazil (ANVISA), a single formatting error can delay revenue by 12 months. SOLENA's Pre-Submission Validator checks against 1,500+ administrative rejection criteria before you submit.
Technical_File_v2.pdf
🔴CRITICAL ERROR DETECTED
Missing ICP-Brasil Digital Signature on Page 4.
Change Material Supplier
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USA:🟢 Letter to File
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EU:🔴 NB Review Required
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China:🟡 Modification Registration
Change Management: One Tweak, Global Impact.
Changing a material supplier? See the global ripple effect instantly. SOLENA maps the regulatory consequence of every change across 52 jurisdictions.