Compliance & Standards
Life sciences compliance standards and regulatory frameworks
Viltis supports pharmaceutical, biotechnology, medical device, diagnostic, and clinical research organizations in implementing, assessing, and maintaining compliance with applicable FDA, EU, ISO, ICH, and GxP requirements.
Browse by industry
Compliance map
Select a category to explore standards and the Viltis services that support them.
Medical Devices & Diagnostics
Quality systems, risk management, market authorization, and post-market compliance for medical devices and IVDs.
Pharmaceutical & Biotechnology
cGMP, inspection readiness, remediation, and validation support for drug and biologic manufacturers.
Clinical Research
GCP frameworks, inspection readiness, TMF quality, and sponsor/vendor oversight for clinical programs.
Pharmacovigilance
GVP-aligned safety systems, case processing, aggregate reporting, and audit readiness.
Digital Systems & Data Integrity
Part 11, Annex 11, CSV/CSA, ALCOA+, and governed digital quality systems.
Laboratories & Supply Chain
Laboratory quality systems, method support, and controlled distribution readiness.
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What are you trying to accomplish?
A problem-oriented path into supporting services.
Standards matrix
Industry → standard → service
A sample of high-priority connections. Full topic lists live inside each category.
| Industry | Standard / framework | Related service |
|---|---|---|
| Medical Devices & Diagnostics | FDA QMSR & ISO 13485 | Quality |
| Medical Devices & Diagnostics | MDSAP Audit Readiness | Quality |
| Pharmaceutical & Biotechnology | FDA cGMP Compliance | Quality |
| Pharmaceutical & Biotechnology | Form 483 & Warning Letter Remediation | Quality |
| Clinical Research | ICH E6(R3) GCP Compliance | Clinical |
| Clinical Research | Clinical Inspection Readiness | Clinical |
| Pharmacovigilance | Aggregate Safety Reporting | Pharmacovigilance |
| Pharmacovigilance | Pharmacovigilance System Master File | Pharmacovigilance |
| Digital Systems & Data Integrity | 21 CFR Part 11 & Annex 11 | Quality |
| Digital Systems & Data Integrity | Computer System Validation (CSV) | Quality |
| Laboratories & Supply Chain | Bioanalytical Sciences | Scientific |
| Laboratories & Supply Chain | Biomarker Development & Validation | Scientific |
Topic hubs link to commercial service pages under Services. For talent and openings, visit Jobs.
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