Qualilab
Qualilab is a French consulting and training firm, founded in 1989 and now part of Biofortis Group, that provides quality management, regulatory affairs, computerized system validation, and statistical data analysis services to pharmaceutical, healthcare, cosmetic, and accredited laboratory clients across France and internationally.
- Company typePrivate
- Founded1989
- HeadquartersOlivet, France
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Qualilab does
Qualilab SAS is a French consulting and training firm founded in 1989 in Orléans, currently headquartered in Olivet (south of Orléans) with additional regional presence in the Paris and Nantes areas. The firm specializes in quality management, regulatory affairs and toxicology, qualification and validation of information systems and analytical methods, and statistical data analysis for clients in highly regulated industries. Its primary verticals are the pharmaceutical industry, accredited laboratories, healthcare/medical biology, the cosmetics industry, the chemical/phytosanitary sector, and biotechnology/medical devices, serving R&D labs, production sites, subcontractors, and government entities (including French hospitals via CAIH framework agreements).
Qualilab's core technology offering includes four SaaS statistical software products (e.noval, Stab.e.lity, Transval, Seelva) distributed under partnership with Pharmalex, which apply the accuracy profile methodology based on total error to physicochemical method validation, stability studies, method transfer, and immunoassay validation. The firm also owns the Qual.e.SI methodology, a 7-step continuous improvement framework for computerized system validation and data integrity in accredited laboratories. Revenue is generated through three streams: project-based consulting engagements, certified training (Qualiopi-certified training organization No. 24.45.04613.45), and annual SaaS subscriptions for its software portfolio. The company typically manages around 100 projects per year with an 11-50 person multidisciplinary team.
Following its departure from the Neovix-Biosciences group at the end of February 2025, Qualilab became part of the Biofortis Group, which maintains operations in Le Plessis-Robinson and Saint-Herblain, France. The firm is directed by Eric Chapuzet, a co-founder since 1989, and maintains active membership in industry associations including SOFAQ, GAMP Francophone, ISPE, A3P, SFSTP, and DMB, alongside university teaching engagements at Orléans and Tours.
Qualilab firmographics
Firmographics- Name
- Qualilab
- Legal name
- Qualilab SAS
- Website
- https://qualilab.com
- Company type
- Private
- Founded year
- 1989
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Qualilab is a French consulting and training firm, founded in 1989 and now part of Biofortis Group, that provides quality management, regulatory affairs, computerized system validation, and statistical data analysis services to pharmaceutical, healthcare, cosmetic, and accredited laboratory clients across France and internationally.
- Ownership category
- akta.pro rank
Qualilab industry classification
Industry- Product category
- Quality Management Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169), Computer Systems Design and Related Services (54151), Medical Laboratories (621511)
- SIC
- Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
- akta.pro secondary industries
- Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Compliance Technology, GRC Platforms & Controls Automation Advisory (BPAHAFAO), QA, Test Automation & Software Quality (Manual/Automated Testing, Performance) (EDABAFAL)
Keywords
Where Qualilab is headquartered
LocationHeadquarters
- HQ city
- Olivet
- HQ country
- France
- HQ region
- Europe
Offices3 records
Markets served
Qualilab business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Consulting Services: Quality management consulting, regulatory affairs and toxicology, qualification/validation services, information systems support, and analytical support. Provided as project-based engagements with expert consultants.
- Training Services: Certified training organization (No. 24.45.04613.45) offering tailored training modules for quality management, information systems, regulatory affairs, analytical support, and data analysis. Training delivered on client premises, at Qualilab offices, or via videoconference.
- Software Distribution: Markets and supports statistical software solutions (e.noval, Stab.e.lity, Transval, Seelva) offered as Software as a Service (SaaS) with annual subscriptions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Software solutions offered as SaaS with annual subscription model |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
Qualilab product offering
Product offeringCore offering
Qualilab is a French consulting and training firm that helps regulated organizations establish and maintain quality management systems, validate analytical methods and computerized systems, ensure data integrity, and comply with GxP, ISO, and FDA/ANSM regulatory requirements. The firm delivers project-based consulting across pharmaceutical, cosmetic, healthcare, biotechnology, chemical, and accredited laboratory sectors, complemented by a certified training organization and SaaS distribution of statistical validation software (e.noval, Stab.e.lity, Transval, Seelva).
Product overview
Qualilab offers a portfolio of four SaaS software products — e.noval, Stab.e.lity, Transval, and Seelva — distributed as Software as a Service solutions requiring only a web browser and internet access. These tools address the analytical method lifecycle: e.noval handles validation of physicochemical methods; Stab.e.lity manages stability studies and expiry criteria; Transval evaluates method transfers between laboratories; and Seelva validates immunoassay methods. All four follow the accuracy profile methodology based on total error and comply with ICH, FDA, ISO, and 21 CFR Part 11 where applicable. Complementing the software, Qualilab provides consulting services across Quality Management, Information Systems, Regulatory Affairs and Toxicology, Analytical Support, and Data Analysis, supported by a structured methodology (Qual.e.SI) for computerized systems management. A certified training organization, Qualilab also delivers tailored training courses in these domains, primarily serving pharmaceutical, cosmetic, medical device, chemical, and healthcare sectors across France.
Differentiator
Problem solved
Functional benefit
Products and services
- e.noval
Quantifiable outcome
- Each year, experts meet with more than 300 contacts and manage around one hundred projects
- +1 more outcomes
Companies that use Qualilab
Customer profileNamed customers4 records
Segments6 records
Ideal customer profiles5 records
Qualilab technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Qualilab partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered minor and core.
- LFB (LFB S.A.)minorCo-hosted conference at Polepharma Biotesting 2025 congress on 'Analytics and Statistics - Key Challenges in Comparability Studies'. Collaborative industry engagement.
- PharmalexcorePharmalex developed and validated software solutions (e.noval, Stab.e.lity, Transval, Seelva) that Qualilab markets and supports in France. These SaaS statistical software tools are dedicated to analytical method validation, stability studies, and method transfer evaluation.
- CAIH (Centrale d'Achat de l'Informatique Hospitalière)coreCAIH selected Qualilab as an approved vendor for computerized system validation services for French hospital centers. Contract established for 4 years covering metropolitan France and overseas departments for validation of computerized systems used in clinical research.
- White-TilletminorCabinet White-Tillet, a regulatory affairs consultancy specializing in medical devices and health products, joined Neovix-Biosciences group in 2021. White-Tillet offers complementary services including technical file documentation, QMS implementation, and training via IFEP.
Scale indicators4 records
Recent moves9 records
Expansion highlights5 records
Qualilab competitors and assessment
Company assessmentDirect peers
- Pharmalex: Developed the e.noval, Stab.e.lity, Transval, and Seelva SaaS suite that Qualilab distributes. Both serve pharma/regulatory affairs clients with software + consulting in analytical method validation — directly overlapping in product and customer base.
- White-Tillet: French regulatory affairs consultancy specializing in medical devices and health products; was a Neovix-Biosciences sister entity. Direct comparable in QMS implementation, technical file documentation, and training.
- Voisin Consulting Life Sciences (VCLS): Regulatory affairs and quality consulting firm serving pharma, biotech, and medical devices. Closely comparable in scope (regulatory, quality, toxicology) and client profile to Qualilab.
Broad incumbents
- Biofortis Group: Qualilab's parent group since Feb 2025, offering complementary services in regulatory affairs, toxicology, and quality across France. Operates in the same quality/regulatory niche with broader service portfolio.
- Eurofins Scientific: Global leader in testing/analytical services with deep pharma and medical-device exposure. Comparable as a quality/compliance support provider, though much larger and broader in scope.
- SGS Life Sciences: Provides quality, regulatory, and laboratory services to pharma and life sciences. Overlaps with Qualilab in regulatory affairs and quality management consulting, but at global scale.
- Bureau Veritas: Testing, inspection, and certification firm serving healthcare/life-sciences with quality and compliance offerings. Comparable in accreditation support and regulatory compliance services.
- Veeva Systems: Cloud software for life sciences including quality/regulatory and validation suites. Competes in adjacent software layer; both serve regulated-life-sciences compliance buyers.
- Capgemini Engineering (Altran): Large IT/digital services firm with life-sciences regulatory and validation consulting practices. Comparable in computer system validation and GxP services, though at far greater scale.
Emerging players
- MasterControl: Quality management / GxP software vendor competing in pharmaceutical QMS and computerized system validation — overlapping with Qualilab's Qual.e.SI methodology and consulting practice.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Qualilab social profiles
Digital presenceQualilab compliance and trust
Trust signalCompliance1 record
Qualilab financial estimates
Financial estimateRevenue estimate
Valuation estimate
Qualilab leadership team
Management profileNumber of profiles
Profiles1 record
Qualilab funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Qualilab 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 Qualilab
What does Qualilab do?
Qualilab is a French consulting and training firm that helps regulated organizations establish and maintain quality management systems, validate analytical methods and computerized systems, ensure data integrity, and comply with GxP, ISO, and FDA/ANSM regulatory requirements. The firm delivers project-based consulting across pharmaceutical, cosmetic, healthcare, biotechnology, chemical, and accredited laboratory sectors, complemented by a certified training organization and SaaS distribution of statistical validation software (e.noval, Stab.e.lity, Transval, Seelva).
Is Qualilab a public or private company?
Qualilab is a private company. It is classified as corporate owned and is currently operating.
When was Qualilab founded?
Qualilab was founded in 1989. It employs 11 to 50 people.
Where is Qualilab based?
Qualilab is headquartered in Olivet, France, in the Europe region.
How does Qualilab make money?
Three revenue lines are on record. Consulting Services are the primary driver. The others are training Services and software Distribution.
Who are Qualilab's main competitors?
Direct peers on record are Pharmalex, White-Tillet and Voisin Consulting Life Sciences (VCLS). Broad incumbents are Biofortis Group, Eurofins Scientific, SGS Life Sciences, Bureau Veritas, Veeva Systems and Capgemini Engineering (Altran). MasterControl is listed as an emerging player.
Does Qualilab have an API?
No public API is recorded for Qualilab.
What industry is Qualilab in?
Qualilab's product category is Quality Management Consulting. Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation, with a secondary code of HLAGAKAK, Laboratory Quality & GLP/GCLP Compliance. Its NAICS code is 54169 and its SIC code is 8734.