Prepare submissions with ease.
Find issues sooner than later.
With ready-to-use templates and direct integration into Lexim Clarit (QMS), generate submission dossiers quickly and easily. Allow team members to review and comment throughout — so gaps are caught by your team, not the agency.
Pathway Structure
510(k), De Novo, Pre-Submission — the right structure applied from the first document. International pathways including EU MDR/IVDR supported.
Collaboration & Review
Team members review, comment, and approve directly within the submission package — structured workflows so nothing falls through the cracks before filing.
Reliance Programs
Leverage your approved submissions in countries participating in Reliance Programs — accelerating market entry without duplicating your regulatory work.
Clarit Integration
Ready-to-use templates and direct integration with Clarit — generate submission dossiers from your existing design history and quality documentation quickly and accurately.
Every pathway. Every jurisdiction. Structured from day one.
Submissions fail on gaps nobody caught — a missing section, an outdated format, a requirement that changed while the package was being assembled. Folio eliminates those failures by structuring submissions correctly from the first document and checking completeness continuously, not just before filing.
US FDA — Device
510(k), PMA, De Novo, Pre-Sub — structured and gap-checked.
Every FDA device submission type supported with pathway-specific structure applied from the first document. Pre-Submission meeting packages prepared. Completeness checked continuously against current FDA requirements — not against a static template from the last submission cycle.
Pharma & Biologics
NDA, BLA, and eCTD formats for FDA, EMA, and international.
eCTD (Electronic Common Technical Document) structure for NDA and BLA submissions to FDA, and for EMA and international equivalents. Folio applies the correct CTD module structure, checks section completeness, and assembles the final eSub package — for both pharma and biologics.
EU & International
EU MDR/IVDR Technical Files and international equivalents.
EU MDR and IVDR Technical File structure applied from day one. International submission formats for PMDA (Japan), Health Canada, TGA (Australia), and other major markets. Multi-jurisdictional submissions managed in parallel without structural inconsistency.
Continuous Completeness Checking
Gaps found when there's still time to close them.
Folio checks every section against pathway requirements continuously throughout preparation — not as a final step before filing. Gaps surface with enough time to address them, not the week before submission.