Validator
Validator K.K. (バリデーター株式会社) is a Japanese validation services and equipment provider founded in 2015, serving pharmaceutical manufacturers, biotech firms, and equipment makers with on-site field validation, proprietary STERIFORCE decontamination systems, and ValGenesis digital validation software distribution.
- Company typePrivate
- Founded2015
- HeadquartersOsaka, Japan
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Validator does
Validator K.K. (バリデーター株式会社) is a Japanese validation services and equipment provider founded in February 2015 and headquartered in Osaka. The company serves pharmaceutical manufacturers, biotechnology and regenerative medicine companies, pharmaceutical equipment manufacturers, and import trading companies across Japan, with operations spanning five domestic offices (West Japan, East Japan, Nagoya/Chubu, Tohoku, Kyushu) and a wholly-owned Vietnam subsidiary established in 2025. Its core offerings include on-site field validation services (HEPA filter integrity testing, air leak testing, airflow/volume testing, temperature mapping, H2O2 decontamination validation), proprietary STERIFORCE chlorine dioxide gas decontamination equipment for biological safety cabinets, LogTag temperature/humidity loggers, Quantumtec cleanroom disinfectants, biological indicators, and consulting on GCTP, GMP, GCP, and sanitation management.
Validator's revenue model combines professional services (field validation and consulting), hardware sales (STERIFORCE systems, STERIFORCE-tab consumables, LogTag instruments, biological indicators, Quantumtec disinfectants), and software resale under the ValGenesis Excellence Partner agreement covering the Validation Lifecycle Management System (VLMS) and its iVal, iClean, and iOps modules. Pricing is contact-based across all streams, with multi-year service contracts typical. The go-to-market is enterprise field sales supplemented by channel resale for the digital validation platform, with demand generation through industry exhibitions (INTERPHEX Tokyo/Osaka, ISPE Japan, Pharma DX EXPO), GMP/GCTP training seminars, and a multilingual Japanese/English/Vietnamese website.
Recent strategic moves include the April 2026 designation as ValGenesis Excellence Partner in Japan, the February 2025 establishment of a Vietnam subsidiary, the September 2024 opening of the Tohoku office, and an underlying July 2024 ValGenesis reseller agreement. The company holds ISO9001 certification (Certificate C2022-03988) covering West and East Japan offices, and employs licensed personnel for biological safety cabinet certification, biosafety management, and specified chemical substances handling. Validator remains privately held, founder-owned and self-funded, with 10 million yen of registered capital and no disclosed external financing.
Validator firmographics
Firmographics- Name
- Validator
- Legal name
- バリデーター株式会社
- Website
- https://validator.co.jp
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Validator K.K. (バリデーター株式会社) is a Japanese validation services and equipment provider founded in 2015, serving pharmaceutical manufacturers, biotech firms, and equipment makers with on-site field validation, proprietary STERIFORCE decontamination systems, and ValGenesis digital validation software distribution.
- Ownership category
- akta.pro rank
Validator industry classification
Industry- Product category
- Pharmaceutical Validation Services
- NAICS
- Testing Laboratories and Services (541380), Testing Laboratories and Services (54138)
- SIC
- Services-Testing Laboratories (8734)
- akta.pro primary industry
- Environmental Monitoring & Cleanroom Testing (GMP) (HLAGADAL)
- akta.pro secondary industry
- Sanitation Chemical Efficacy Testing & Disinfectant Validation (Quat/PAA Verification) (AFALAEAL)
Keywords
Where Validator is headquartered
LocationHeadquarters
- HQ city
- Osaka
- HQ country
- Japan
- HQ region
- Asia
Offices6 records
Markets served
Validator business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure, Supply Chain
Revenue model
- Validation Services: On-site field validation services for isolators, clean rooms, incubators, biological safety cabinets, and other pharmaceutical equipment. Includes HEPA filter integrity testing, air leak testing, air velocity/volume testing, H2O2 decontamination validation.
- Software Resale (ValGenesis VLMS): Resale of ValGenesis Validation Lifecycle Management System in Japan as Excellence Partner. Includes iVal, iClean, and iOps modules for paperless validation.
- Decontamination Equipment Sales: Sale of STERIFORCE chlorine dioxide gas decontamination systems for safety cabinets, biological indicators, and related validation tools.
- Consulting Services: GCTP, GMP, GCP, sanitation management, and decontamination cycle development consulting for pharmaceutical and regenerative medicine facilities.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom validation services tailored to client equipment and requirements |
| Unit Pricing | Multi-year contract | Decontamination equipment and validation tools |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
Validator product offering
Product offeringCore offering
Validator K.K. provides on-site field validation services for pharmaceutical equipment (isolators, cleanrooms, biological safety cabinets, incubators, sterilizers, refrigerators, freezers) covering HEPA filter integrity testing, air leak testing, airflow testing, H2O2 decontamination validation, and temperature mapping. The company also manufactures and sells the proprietary STERIFORCE chlorine dioxide gas decontamination system for safety cabinets, resells ValGenesis VLMS digital validation software as Japan's Excellence Partner, distributes LogTag temperature loggers, biological indicators, and Quantumtec cleanroom disinfectants, and delivers GCTP/GMP/GCP consulting services for pharmaceutical and regenerative medicine facilities.
Product overview
Validator K.K. operates as a validation services provider and product distributor for the life sciences industry, offering both proprietary products and ValGenesis digital validation software. The core product portfolio includes STERIFORCE, a Japan-made chlorine dioxide gas decontamination system for biological safety cabinets, supplemented by LogTag temperature measurement instruments, biological indicators, and Quantumtec cleanroom disinfectants. The company also resells and implements ValGenesis digital validation solutions comprising the VLMS (Validation Lifecycle Management System) as the central platform, augmented by AI-powered modules including iVal for automated validation authoring, iClean for cleaning validation automation, and iOps for paperless digital logbooks. Services include on-site field validation for pharmaceutical equipment and consulting for GCTP, GMP, and regulatory compliance.
Differentiator
Problem solved
Functional benefit
Brands
- STERIFORCE: Decontamination equipment brand for safety cabinets using chlorine dioxide gas. The brand name combines STERI (sterilization) and FORCE (strength), and is registered as a trademark for products and services.
Products and services
- STERIFORCE Chlorine Dioxide Decontamination System Japan-made decontamination equipment for biological safety cabinets using fixed-concentration chlorine dioxide gas method (NSF/ANSI49). Decontaminates safety cabinets in approximately 1 hour while monitoring and controlling gas concentration at constant levels. Includes built-in gas scrubber for decomposition after decontamination. Sold to pharmaceutical manufacturers and biotech companies.
- STERIFORCE-tab Specialized tablet system for generating chlorine dioxide solution used with STERIFORCE decontamination equipment. Tablets are specially processed to be handled as non-deleterious goods before opening, with one tablet sufficient to produce chlorine dioxide solution. Sold to pharmaceutical safety cabinet users.
- LogTag Temperature and Humidity Loggers Temperature and humidity measurement instruments for pharmaceutical transport GDP compliance and IEC temperature mapping. Includes validation-purpose temperature data loggers with ISO 9001-scoped calibration services. Sold to pharmaceutical manufacturers and logistics operations.
- Biological Indicators Microbial control and decontamination validation tools including biological indicators for peracetic acid, hydrogen peroxide, and chlorine dioxide gas (MESALabs ACD/6 Bacillus atrophaeus, Log6). Includes rapid-determination indicators, chemical indicators, and contracted incubation services. Sold to pharmaceutical validation and quality control teams.
- Quality Control AI Software AI software for quality control applications including inspection AI for production lines and cell monitoring AI for cell counting and observation tasks. Sold to pharmaceutical manufacturers and regenerative medicine companies.
- Quantumtec Cleanroom Disinfectants Pharmaceutical cleanroom disinfectants designed in USA and manufactured in Malaysia, available for Grade A to D applications across Asian markets. Product line includes 70% denatured ethanol (filtered, gamma-sterilized), sodium hypochlorite 0.52%, quaternary ammonium salts, peracetic acid, and concentrated detergents. Sold to pharmaceutical cleanroom operators.
- ValGenesis VLMS (Validation Lifecycle Management System) Comprehensive validation lifecycle management platform covering concept to documentation, execution, storage, approval, and audit response. Incorporates risk-based approaches and supports URS, CSV, CQV workflows using Yes/No charts with hyperlink-based document navigation. Enables paperless validation with 50%+ process efficiency improvement. Resold and implemented in Japan by Validator K.K. as ValGenesis Excellence Partner for pharmaceutical manufacturers and biotech companies.
- ValGenesis iVal AI-powered validation authoring module that enables automated document creation, real-time anomaly detection, and bulletproof traceability. Reduces validation cycle time by up to 80% and cuts observation monitoring effort by 90%. Supports transition from CQV to CSA approaches. Sold as part of the ValGenesis VLMS suite to pharmaceutical companies.
- ValGenesis iClean Cleaning validation module that automates MACO calculations, applies ADE-aligned limits, provides 2D/3D equipment mapping, and delivers rule-driven workflows. Halves cleaning validation timelines and eliminates manual calculations. Sold to pharmaceutical quality assurance teams.
- ValGenesis iOps Digital logbook replacement module using mobile QR-enabled forms for real-time recording of use, cleaning, and calibration events. Achieves 100% traceability and reduces documentation labor by 70% with automated reviews and deviation alerts. Sold to pharmaceutical manufacturing operations.
- Field Validation Services On-site validation services for pharmaceutical equipment including isolators, cleanrooms (ICR/BCR), incubators, biological safety cabinets, centrifuges, sterilizers, refrigerators, and freezers. Services include HEPA filter integrity testing, air leak testing, airflow testing, H2O2 decontamination validation, temperature mapping, and photometer testing. Delivered by Validator K.K. field staff across Japan to pharmaceutical manufacturers and biotech companies.
- Consulting Services Consulting services covering GCTP, GMP, clinical trial GCP, sanitation management, and decontamination cycle development. Includes regenerative medicine facility management consulting, validation master plan creation, and environmental microorganism monitoring with H2O2 decontamination effectiveness confirmation. Delivered to pharmaceutical and regenerative medicine facilities.
Quantifiable outcome
- Validation lifecycle process efficiency improved by 50% or more using ValGenesis VLMS
- +3 more outcomes
Companies that use Validator
Customer profileSegments4 records
Ideal customer profiles3 records
Validator technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature4 records
Validator partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- ValGenesis Inc.coreValidator K.K. designated as Excellence Partner in Japan, responsible for implementing ValGenesis digital validation solutions across Japan's life sciences sector. Under the partnership, Validator K.K. resells ValGenesis' Validation Lifecycle Suite and serves as referral partner for the Process Lifecycle Suite. The collaboration enables Japanese pharmaceutical and biotech companies to address regulatory compliance, labor shortages, and digitalization challenges through digital validation.
Scale indicators4 records
Recent moves14 records
Expansion highlights7 records
Validator competitors and assessment
Company assessmentDirect peers
- PharmaLex (Cencora): Regulatory affairs, quality, and validation consulting provider to pharma and biotech. Comparable to Validator's GCTP/GMP/GCP consulting practice and equipment/facility qualification work.
- Commissioning Agents Inc. US-headquartered CQV (commissioning, qualification, validation) services firm serving pharmaceutical and biotech manufacturers. Directly comparable to Validator's field validation services business model and pharma/biotech end-market focus.
- CRB Group: Engineering, construction, and consulting firm specializing in life sciences facilities, including validation and qualification services. Directly comparable in CQV execution, cleanroom validation, and pharma/biotech end-market focus.
- PM Group: International engineering, architecture, and validation consultancy serving pharmaceutical and life sciences clients. Directly comparable to Validator's on-site validation, CQV, and GMP/GCTP consulting offerings.
Regional players
- Taisei Engineering Consultants: Japanese engineering consultancy providing pharmaceutical facility validation, GMP compliance, and cleanroom qualification services. Comparable to Validator's field validation and consulting business within the Japanese market.
- Azbil Corporation: Japanese building automation and control company with life sciences validation capabilities for cleanrooms and pharmaceutical facilities. Comparable as a Japan-headquartered player addressing GMP-compliant building and equipment qualification.
- Yokogawa Electric: Japanese industrial automation supplier with life sciences solutions including plant-wide validation, GMP compliance, and pharma manufacturing digitalization — overlapping with Validator's software-enabled paperless validation proposition in the Japanese market.
Broad incumbents
- STERIS Corporation: Global leader in sterilization, decontamination, and contamination control products and services. Comparable to Validator because STERIS sells competing decontamination equipment for biological safety cabinets and cleanrooms and offers adjacent validation/qualification services globally.
- Ecolab Life Sciences: Global supplier of cleanroom disinfectants (including the Klercide product line) that competes directly with Validator's Quantumtec disinfectant portfolio for Grade A–D pharmaceutical cleanrooms across Asia.
- ValGenesis Inc. Vendor of the VLMS, iVal, iClean, and iOps platforms that Validator resells under the Excellence Partner agreement. Comparable as the upstream platform supplier whose technology underpins Validator's paperless validation offering.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Validator social profiles
Digital presenceValidator compliance and trust
Trust signalCompliance1 record
Validator financial estimates
Financial estimateRevenue estimate
Valuation estimate
Validator leadership team
Management profileNumber of profiles
Profiles4 records
Validator subsidiaries and ownership
Company hierarchySubsidiaries1 record
Validator funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Validator 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 Validator
What does Validator do?
Validator K.K. provides on-site field validation services for pharmaceutical equipment (isolators, cleanrooms, biological safety cabinets, incubators, sterilizers, refrigerators, freezers) covering HEPA filter integrity testing, air leak testing, airflow testing, H2O2 decontamination validation, and temperature mapping. The company also manufactures and sells the proprietary STERIFORCE chlorine dioxide gas decontamination system for safety cabinets, resells ValGenesis VLMS digital validation software as Japan's Excellence Partner, distributes LogTag temperature loggers, biological indicators, and Quantumtec cleanroom disinfectants, and delivers GCTP/GMP/GCP consulting services for pharmaceutical and regenerative medicine facilities.
Is Validator a public or private company?
Validator is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Validator founded?
Validator was founded in 2015. It employs 11 to 50 people.
Where is Validator based?
Validator is headquartered in Osaka, Japan, in the Asia region.
How does Validator make money?
Four revenue lines are on record. Validation Services are the primary driver. The others are software Resale (ValGenesis VLMS), decontamination Equipment Sales and consulting Services.
Who are Validator's main competitors?
Direct peers on record are PharmaLex (Cencora), Commissioning Agents Inc., CRB Group and PM Group. Regional players are Taisei Engineering Consultants, Azbil Corporation and Yokogawa Electric. Broad incumbents are STERIS Corporation, Ecolab Life Sciences and ValGenesis Inc..
Does Validator have an API?
No public API is recorded for Validator.
What industry is Validator in?
Validator's product category is Pharmaceutical Validation Services. Its primary akta.pro industry code is HLAGADAL, Environmental Monitoring & Cleanroom Testing (GMP), with a secondary code of AFALAEAL, Sanitation Chemical Efficacy Testing & Disinfectant Validation (Quat/PAA Verification). Its NAICS code is 541380 and its SIC code is 8734.