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Services
Regulatory
Expert regulatory consulting for pharmaceuticals, medical devices, and biologics across FDA and EU pathways.
Overview
Regulatory consulting at Viltis helps organizations plan FDA and EU pathways, prepare meetings and submissions, and keep post-approval obligations from slipping. Work covers strategy, regulatory operations, inspection readiness, promotional review, and device frameworks such as MDR and IVDR.
Clients typically need this when a filing clock is real, agency feedback is ambiguous, or labeling and post-market changes need controlled ownership. We bring people who have lived those cycles - not generalists learning your product class on the first call.
Explore the capabilities listed for this practice area, or contact us to map the next regulatory step for your portfolio. Viltis is not a Notified Body and does not issue certificates or marketing authorizations.
Regulatory capabilities in this practice area include
- FDA Regulatory Strategy and Meeting Consulting
- Regulatory Operations and Intelligence
- Market Access & Reimbursement Strategy
- Advertising & Promotional Review (OPDP)
- FDA Inspection Readiness and Post-Approval Maintenance
- EU MDR and EU IVDR support
- Global Regulatory Considerations across FDA and EU pathways
Featured capabilities
Where teams typically start
Full directory
All Regulatory capabilities
Market Access & Reimbursement Strategy
Advertising & Promotional Review (OPDP)
Regulatory Intelligence & Guidance Monitoring
FDA Inspection Readiness
Post-Approval Regulatory Maintenance
EU MDR (Medical Device Regulation)
EU IVDR (In Vitro Diagnostic Regulation)
Global Regulatory Considerations (FDA and EU MDR/IVDR)
Medical Device Submissions: 510(k), De Novo and PMA
IEC 62304 Medical Device Software and SaMD
Medical Device Cybersecurity
Need regulatory support?
Discuss scope, timelines, and the specialists required for your program.