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.

Schedule a Consultation

Quality

GMP, GCP, and ISO 13485 quality experts — audit-ready, experienced, and regulatory-aligned.

Clinical

Clinical consulting across pharmaceuticals, medical devices, and biologics — from trial operations to real-world evidence.

Regulatory

Expert regulatory consulting for pharmaceuticals, medical devices, and biologics across FDA and EU pathways.

Engineering

Process engineering, validation, facilities qualification, and manufacturing readiness for regulated environments.

Scientific

Scientific and technical consulting across nonclinical development, CMC, bioanalytics, and due diligence.

Pharmacovigilance

Drug safety, ICSR management, signal detection, and global pharmacovigilance compliance across development and post-market.

How can we help?

Tell us about your program needs and timeline. Our team will respond promptly.

info@viltis.com(619) 324-8776

Schedule a Call

Expert solutions across the regulated product lifecycle

Quality

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

Clinical

Pharmaceutical

Medical Devices

Biologics

Full-Service CRO

Decentralized Clinical Trials

Embedded Clinical Solutions

Biostatistics & Programming

Medical Writing & Transparency

Clinical Operations Management

Study Startup & Site Activation

Clinical Data Management

Real-World Evidence (RWE)

Regulatory

FDA Regulatory Strategy and Consulting

FDA Meeting Consulting Services

Regulatory Operations

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)

Engineering

Commissioning, Qualification & Validation (CQV)

Facilities & Equipment Qualification

Manufacturing Readiness & Technical Transfer

Engineering Change Control & Lifecycle Management

Utilities & Cleanroom Systems Qualification

Process Engineering & Scale-Up Support

Automation & Control Systems (GxP)

Equipment Reliability & Preventive Maintenance

Scientific

Nonclinical Development

Translational Science

Scientific & Technical Consulting

Bioanalytical Sciences

Chemistry, Manufacturing, and Controls (CMC) Scientific Support

Nonclinical Toxicology Strategy

Biomarker Development & Validation

Scientific Due Diligence & Program Assessment

Pharmacovigilance

Adverse Event Reporting Across Clinical Trials and Post-Market

Comprehensive ICSR Management for Global Compliance

Proactive Signal Detection and Risk Management in Drug Safety

Pharmacovigilance Gap Analysis: Strengthening Your Compliance Framework

Post-Market Surveillance: Ensuring Ongoing Drug Safety

Literature Surveillance for Pharmacovigilance: Tracking Emerging Risks

Preparing for Pharmacovigilance Audits: Best Practices for Compliance

Internal Pharmacovigilance Audits: Ensuring Regulatory Readiness

The Role of the QPPV in Ensuring Global Pharmacovigilance Compliance

Meeting European Pharmacovigilance Standards with QPPV Oversight

Observational Studies and Real-World Evidence in Drug Safety

How can we help?