Viltis
Viltis is a privately-held life sciences consulting firm providing regulatory, quality, clinical, engineering, scientific, and pharmacovigilance consulting and staff augmentation to pharmaceutical, biotechnology, medical device, and diagnostics organizations across the United States.
- Company typePrivate
- Founded2020
- HeadquartersDel Mar, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Viltis does
Viltis is a privately-held life sciences consulting firm founded in 2020 and headquartered in San Diego, California, with an additional operational presence in San Carlos, CA. The firm sells expert consulting and flexible resourcing across six practice areas: Quality (GxP compliance, inspection readiness, CSV, validation, data integrity), Clinical (clinical operations, biostatistics, decentralized trials, RWE), Regulatory (FDA strategy, EU MDR/IVDR, regulatory intelligence, advertising/promotional review), Engineering (commissioning/qualification, facilities, automation, scale-up), Scientific (nonclinical development, CMC, bioanalytics, due diligence), and Pharmacovigilance (ICSR management, signal detection, literature surveillance, QPPV). Engagement models include strategic consulting projects, dynamic staff augmentation, full-time expert recruitment, and a Functional Service Provider (FSP) model for longer-tenured embedded teams. Its primary buyer is the regulated life sciences enterprise — pharmaceutical sponsors, biotech developers (vaccines, gene/cell therapies, biologics), medical device manufacturers (including Class I and cardiovascular), and in-vitro diagnostics companies navigating FDA and EU regulatory pathways.
Service delivery leans on practitioner expertise rather than a unified software platform. Documented technology components include advanced pharmacovigilance databases that automate case intake, duplicate detection, and follow-up; AI-driven tooling for continuous monitoring of global medical literature; and integration with digital health platforms for real-time adverse event reporting and patient monitoring. The firm does not disclose proprietary models, patents, or in-house AI/ML research, and AI capabilities are framed as workflow augmentation rather than a productized offering.
Viltis operates a sales-led, direct-engagement model. Organizations initiate contact through the website's "Schedule a Consultation" and "Request Consultant Support" CTAs or via [email protected]. Marketing is content-led (industry blog, case studies, LinkedIn presence) targeting top- and mid-funnel awareness in regulated life sciences markets, with bottom-of-funnel conversion through consultation requests. Pricing is quote-based, customized by engagement type, consultant seniority, and project scope, with reference to multi-year contracts. Documented enterprise engagements include Abbott Cardiovascular (mechanical engineering and CAD for stent/guidewire development), GBT (multi-disciplinary team of 12 consultants through Phase III BLA preparation and eventual Pfizer acquisition), a Phase III biologics sponsor, a Class I medical device manufacturer (EU MDR DHF remediation), and a global healthcare company (20+ engineers mobilized for COVID-19 test kit manufacturing restart). The company is privately held with no disclosed funding rounds, parent company, or ownership structure.
Viltis firmographics
Firmographics- Name
- Viltis
- Legal name
- Viltis
- Website
- https://viltis.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Viltis is a privately-held life sciences consulting firm providing regulatory, quality, clinical, engineering, scientific, and pharmacovigilance consulting and staff augmentation to pharmaceutical, biotechnology, medical device, and diagnostics organizations across the United States.
- Ownership category
- akta.pro rank
Viltis industry classification
Industry- Product category
- Life Sciences Consulting
- NAICS
- Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Pharmacovigilance, Drug Safety & Risk Management FSP (HLAGAOAF)
- akta.pro secondary industries
- Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA), Preclinical, Toxicology & Translational Science Staffing FSP (HLAGAOAJ)
Keywords
Where Viltis is headquartered
LocationHeadquarters
- HQ city
- Del Mar
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Viltis business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Strategic Consulting Engagements: Project-based consulting engagements supporting organizations navigating complex challenges, inflection points, or periods of change. These deliver analysis, recommendations, and execution support for regulatory, quality, clinical strategy, inspection readiness, and remediation planning.
- Dynamic Staff Augmentation: Flexible access to experienced professionals who integrate into existing teams and workflows. Supports periods of increased workload, specialized needs, or temporary resource gaps without requiring long-term hiring commitments.
- Full-Time Expert Recruitment: Recruitment services identifying candidates with technical expertise, leadership capability, and cultural fit for long-term internal team positions across regulatory affairs, quality assurance, clinical operations, and technical operations.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Consulting services are customized to client needs with quote-based pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Viltis product offering
Product offeringCore offering
Viltis is a life sciences consulting firm that provides expert consultants and professional services across six practice areas: Quality, Clinical, Regulatory, Engineering, Scientific, and Pharmacovigilance. The company serves pharmaceutical, biotechnology, medical device, and diagnostics organizations through flexible engagement models including Strategic Consulting, Dynamic Staff Augmentation, and Full-Time Expert Recruitment (FSP). Services span the regulated product lifecycle from development through commercialization, with emphasis on FDA regulatory compliance, inspection readiness, clinical operations, CMC, and drug safety.
Product overview
Viltis is a life sciences consulting firm offering a portfolio of professional services across six core practice areas: Quality, Clinical, Regulatory, Engineering, Scientific, and Pharmacovigilance. The company provides flexible engagement models including Strategic Consulting, Dynamic Staff Augmentation, and Full-Time Expert Recruitment. Services span the regulated product lifecycle from development through commercialization, supporting pharmaceutical, biotech, medical device, and diagnostics organizations. Viltis does not offer a unified software platform but rather deploys experienced consultants and project teams to address client needs in regulatory compliance, quality assurance, clinical operations, engineering validation, scientific expertise, and drug safety.
Differentiator
Problem solved
Functional benefit
Products and services
- Quality Services Quality consulting covering GMP, GCP, and ISO 13485 quality experts delivering GxP Compliance & Auditing, Inspection Readiness, Computer System Validation, Commissioning Qualification & Validation, Clinical Quality Assurance, Data Integrity & ALCOA+ Compliance, and QA for Digital Systems & Emerging Technologies for life sciences organizations.
- Clinical Services
- Regulatory Services
- Engineering Services
- Scientific Services
- Pharmacovigilance Services
- Contingent Resourcing
- Sourcing Project Teams
- Functional Service Provider (FSP)
Quantifiable outcome
- Qualified QA experts deployed within 2 weeks; senior consultant placed within 4 days for FDA inspection support
- +3 more outcomes
Companies that use Viltis
Customer profileNamed customers6 records
Segments4 records
Ideal customer profiles3 records
Viltis technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Viltis partnerships and signals
Strategic signalScale indicators5 records
Recent moves5 records
Expansion highlights5 records
Viltis competitors and assessment
Company assessmentDirect peers
- Accent Group (Accent on Biologics): Pharmacovigilance and quality consulting focused on biologics and complex therapies. Highly comparable to Viltis's PV/biologics CMC combination and inspection-readiness work.
- PharmaLex: Regulatory affairs, pharmacovigilance, and quality consulting practice for pharma and biotech. Comparable to Viltis in regulatory strategy, PV/QPPV, and clinical consulting scope.
- qPharmetra: Specialist pharmacovigilance and drug safety consulting firm serving pharma/biotech with QPPV, signal detection, and ICSR capabilities—matching Viltis's dedicated PV practice.
- MMS Holdings: Pharmaceutical services firm specializing in regulatory, pharmacovigilance, and clinical support for small and mid-sized pharma. Directly comparable to Viltis's PV, regulatory, and biologics CMC focus and FSP-adjacent delivery.
- ProPharma Group: Life sciences consulting firm providing regulatory, pharmacovigilance, quality, and clinical services to pharma/biotech. Closely comparable to Viltis's service portfolio and FSP/consulting engagement model across pharma and biotech buyers.
- Veristat: Clinical and regulatory consulting firm supporting small/mid-sized biopharma through approval and post-approval. Comparable to Viltis on the clinical, regulatory, and BLA-readiness dimensions.
Broad incumbents
- Certara: Larger life-sciences technology-enabled consulting and regulatory science provider with strong PV and regulatory modeling capabilities. Overlaps with Viltis on regulatory strategy and pharmacovigilance but operates at materially greater scale.
- Parexel: Global CRO with substantial regulatory, PV, and FSP service lines serving large pharma. Competes with Viltis for the same enterprise buyers and mandates but at full-service scale.
- ICON plc: Global CRO offering clinical, regulatory, and FSP services to pharma/biotech. Overlaps with Viltis on clinical operations, regulatory, and embedded team engagements.
- IQVIA: Largest global CRO with deep regulatory, quality, PV, and FSP capabilities. Competes head-to-head with Viltis on staff-aug/FSP and regulatory consulting mandates.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
Viltis social profiles
Digital presenceViltis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Viltis leadership team
Management profileNumber of profiles
Viltis funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Viltis M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Viltis
What does Viltis do?
Viltis is a life sciences consulting firm that provides expert consultants and professional services across six practice areas: Quality, Clinical, Regulatory, Engineering, Scientific, and Pharmacovigilance. The company serves pharmaceutical, biotechnology, medical device, and diagnostics organizations through flexible engagement models including Strategic Consulting, Dynamic Staff Augmentation, and Full-Time Expert Recruitment (FSP). Services span the regulated product lifecycle from development through commercialization, with emphasis on FDA regulatory compliance, inspection readiness, clinical operations, CMC, and drug safety.
When was Viltis founded?
Viltis was founded in 2020. It employs 1 to 10 people.
Where is Viltis based?
Viltis is headquartered in Del Mar, United States, in the North America region.
How does Viltis make money?
Three revenue lines are on record. Strategic Consulting Engagements are the primary driver. The others are dynamic Staff Augmentation and full-Time Expert Recruitment.
Who are Viltis's main competitors?
Direct peers on record are Accent Group (Accent on Biologics), PharmaLex, qPharmetra, MMS Holdings, ProPharma Group and Veristat. Broad incumbents are Certara, Parexel, ICON plc and IQVIA.
Does Viltis have an API?
No public API is recorded for Viltis.
What industry is Viltis in?
Viltis's product category is Life Sciences Consulting. Its primary akta.pro industry code is HLAGAOAF, Pharmacovigilance, Drug Safety & Risk Management FSP, with a secondary code of HLAGAAAH, Pharmacovigilance, Risk Management & Medical Affairs CROs. Its NAICS code is 54161 and its SIC code is 8742.