Related engagement
Biologics CMC Analytical Dev. Consultant
Phase III biologics analytical development support with LCMS expertise and new CRO relationships.
Services
Quality
GMP, GCP, and ISO 13485 quality experts - audit-ready, experienced, and regulatory-aligned.
Overview
Quality work at Viltis covers the systems and day-to-day controls that keep pharmaceutical, biologics, and medical device programs inspection-ready. That includes GxP auditing, CSV, CQV, clinical quality, and data integrity - staffed with people who have already worked those processes under FDA scrutiny.
Teams usually call when audits are overdue, CAPAs keep reopening, a system go-live needs Part 11 evidence, or an inspection window is approaching. We embed with quality and operations so the fix lives in the SOP and on the floor, not only in a slide deck.
Browse the capabilities in this practice area for the specific support you need, or contact us if you want help choosing where to start. Viltis provides consulting and resourcing; we do not issue regulatory certificates.
Quality capabilities in this practice area include
- GxP Compliance & Auditing
- Inspection Readiness (Quality)
- Computer System Validation (CSV)
- Commissioning, Qualification & Validation (CQV)
- Clinical Quality Assurance (CQA)
- Data Integrity & ALCOA+ Compliance
- QA for Digital Systems & Emerging Technologies
Featured capabilities
Where teams typically start
Full directory
All Quality capabilities
Commissioning, Qualification & Validation (CQV)
Clinical Quality Assurance (CQA)
Data Integrity & ALCOA+ Compliance
QA for Digital Systems & Emerging Technologies
FDA QMSR and ISO 13485 Quality System Consulting
MDSAP Audit Readiness and Remediation
FDA cGMP Compliance Consulting
FDA Form 483 and Warning Letter Remediation
21 CFR Part 11 and EU Annex 11 Compliance
Computer Software Assurance (CSA)
CAPA, Deviation and OOS Remediation
ISO 14971 Medical Device Risk Management
Medical Device Design Controls and DHF Remediation
Need quality support?
Discuss scope, timelines, and the specialists required for your program.