01
Quality
GMP, GCP, and ISO 13485 quality experts - audit-ready, experienced, and regulatory-aligned.
Services
Expert solutions across the regulated product lifecycle
From quality and regulatory affairs to clinical operations, engineering validation, and drug safety - Viltis delivers experienced professionals when you need them.
02
Clinical
Clinical consulting across pharmaceuticals, medical devices, and biologics - from trial operations to real-world evidence.
03
Regulatory
Expert regulatory consulting for pharmaceuticals, medical devices, and biologics across FDA and EU pathways.
04
Engineering
Process engineering, validation, facilities qualification, and manufacturing readiness for regulated environments.
05
Scientific
Scientific and technical consulting across nonclinical development, CMC, bioanalytics, and due diligence.
06
Pharmacovigilance
Drug safety, ICSR management, signal detection, and global pharmacovigilance compliance across development and post-market.
Featured capabilities
Comprehensive ICSR Management for Global Compliance
Proactive Signal Detection and Risk Management in Drug Safety
Aggregate Safety Reporting: DSUR, PBRER and PSUR
Pharmacovigilance System Master File (PSMF)
Post-Market Surveillance: Ensuring Ongoing Drug Safety
The Role of the QPPV in Ensuring Global Pharmacovigilance Compliance
Lifecycle
Where Viltis supports the product journey
Capabilities map across strategy through commercialization and remediation - a second way to understand how we engage.
StrategyDevelopmentValidationSubmissionCommercializationRemediation
Not sure where to start?
Tell us about your program stage and compliance priorities. We will help you identify the right practice area.