Apsalys
Apsalys is a French consulting and systems integration firm that serves as the exclusive distributor of MasterControl's eQMS platform for French-speaking countries, providing quality management, audit, regulatory affairs, and computerized system validation services to pharmaceutical, medical device, and other regulated industries.
- Company typePrivate
- Founded2004
- HeadquartersAsnières-sur-vègre, France
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Apsalys does
Apsalys is a French consulting and systems integration firm founded in 2004, headquartered in Bordeaux with a secondary office in Pessac, operating with 1–10 employees under founder Philippe Charbon. The company is specialized in the consulting and integration of Quality Management System (QMS) and regulatory compliance solutions for life sciences, with deep expertise in pharmaceutical manufacturing, medical devices, and Software as a Medical Device (SaMD). It serves as the exclusive official distributor and integrator of MasterControl for French-speaking countries, distributing and implementing the MasterControl platform's modules: eQMS for quality document management, Manufacturing Excellence (Mx) with electronic Batch Records, LogBooks for digital equipment logging, and AQEM for quality event management.
The company's service portfolio complements the software distribution with QMS implementation consulting, internal and supplier audits, regulatory affairs support (including technical files, post-market surveillance, and CE marking preparation), and computerized system validation (CSV) under GAMP 5, 21 CFR Part 11, Annex 11/15 GMP, and EU MDR. Credentials span ISO 13485, ISO 9001, ISO 27001, EU MDR 2017/745, FDA 21 CFR Part 11/820, and GxP frameworks. A documented flagship engagement is the bioMérieux implementation of MasterControl Manufacturing Excellence to replace paper-based 250+ page batch record logbooks across an operation producing over 100 million products annually.
Apsalys generates revenue through two streams: subscription-based MasterControl software distribution and integration (recurring) and professional consulting services. Pricing is quote-based with multi-year contracts and no publicly disclosed tiers. The firm is a member of AFNOR Normalization Commission S95B and holds memberships in A3P, SOFAQ, POLEPHARMA, TIC-SANTÉ, and ALLIS-NA, supporting both regulatory influence and pipeline generation across the francophone regulated industries market.
Apsalys firmographics
Firmographics- Name
- Apsalys
- Legal name
- Apsalys
- Website
- https://apsalys.com
- Company type
- Private
- Founded year
- 2004
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Apsalys is a French consulting and systems integration firm that serves as the exclusive distributor of MasterControl's eQMS platform for French-speaking countries, providing quality management, audit, regulatory affairs, and computerized system validation services to pharmaceutical, medical device, and other regulated industries.
- Ownership category
- akta.pro rank
Apsalys industry classification
Industry- Product category
- Life Sciences Regulatory & Quality Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169), Professional, Scientific, and Technical Services (54)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
- akta.pro secondary industry
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)
Keywords
Where Apsalys is headquartered
LocationHeadquarters
- HQ city
- Asnières-sur-vègre
- HQ country
- France
- HQ region
- Europe
Offices2 records
Markets served
Apsalys business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- MasterControl Software Distribution and Integration: As the exclusive official provider of MasterControl for francophone countries, Apsalys generates revenue through software distribution, implementation, and integration services for the MasterControl eQMS and manufacturing platforms.
- Consulting Services: Professional consulting services including QMS implementation and optimization, audits (internal and supplier), regulatory affairs, and computerized system validation (CSV). Services are delivered through personalized engagement and may involve multi-day on-site or video conference interventions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Contact for pricing - no public pricing available |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels5 records
Apsalys product offering
Product offeringCore offering
Apsalys is the exclusive official distributor and integrator of the MasterControl SaaS platform for French-speaking countries, specializing in electronic Quality Management (eQMS), Manufacturing Excellence with electronic batch records, LogBooks, and AQEM for life sciences and regulated industries. The company complements the platform with professional consulting services including QMS implementation, internal and supplier audits, regulatory affairs support (CE marking, MDR compliance, post-market surveillance), and Computerized System Validation aligned to FDA 21 CFR Part 11, EU MDR, ISO 13485, and GxP frameworks.
Product overview
Apsalys is a French company serving life sciences, regulatory affairs, and information systems markets as the exclusive official distributor and integrator of MasterControl for French-speaking countries. The core offering is the MasterControl platform—a modular SaaS quality management ecosystem comprising eQMS for quality document management, Manufacturing Excellence (Mx) for electronic batch records and manufacturing execution, LogBooks for digital equipment logging, and AQEM for quality event management. Apsalys complements the platform with professional consulting services including QMS implementation, internal and supplier audits, regulatory affairs (technical files, PMS, dossier submission), and computerized system validation (CSV). The company specializes in ISO 13485, GxP, FDA 21 CFR Part 11/820, and EU MDR compliance for pharmaceutical, medical device, and other regulated industries.
Differentiator
Problem solved
Functional benefit
Products and services
- MasterControl Platform (exclusive francophone distribution) SaaS quality management platform for regulated industries offering connected solutions for document management, audit management, training management, risk management, and manufacturing execution, distributed exclusively by Apsalys in French-speaking countries.
- MasterControl LogBooks Digital solution for creating, issuing, executing, and reviewing equipment and process logbooks in 100% digital format, replacing paper-based logging for life sciences manufacturers.
- MasterControl AQEM Advanced Quality Event Management platform for efficient and simple handling and management of quality events in regulated environments.
- QMS Consulting Services Quality Management System consulting including audit, implementation, training, and ongoing support for ISO 9001 and ISO 13485 compliance in regulated companies.
- Audit Services Internal and supplier audits for regulated companies covering BPF, BPL, ISO 13485, ISO 27001, MDR (EU) 2017/745, 21 CFR Part 820, and CFR 21 Part 11 frameworks.
- Regulatory Affairs Services Regulatory compliance support including technical file updates, post-market surveillance (PMS), dossier submission, and CE marking preparation under EU MDR 2017/745 for medical device and pharmaceutical clients.
- Computerized System Validation (CSV) Validation services for computerized systems ensuring compliance with 21 CFR Part 11, Annex 11 GMP, Annex 15 GMP, and EU MDR requirements, following GAMP 5 and PIC/S guidance.
- MasterControl Implementation Services End-to-end MasterControl implementation services including needs assessment, configuration, user training, and ongoing support for regulated industry clients.
Quantifiable outcome
- bioMérieux implemented eBR replacing 250+ page paper logbooks, improving data access and integrity
- +1 more outcomes
Companies that use Apsalys
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles3 records
Apsalys technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
AI capability6 records
Feature5 records
Apsalys partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered strategic, core and minor.
- AFNOR Normalisation - Commission S95BstrategicApsalys became a member of AFNOR's Normalization Commission S95B (Quality Management and General Quality aspects for Medical Devices) effective January 1, 2022. This commission addresses harmonized standards for EU MDR 2017/745 and IVDR 2017/746 compliance, helping manufacturers obtain CE marking.
- MasterControlcoreApsalys is the exclusive official provider and distributor of MasterControl solutions for the French-speaking (francophone) market. The partnership covers distribution, implementation, and integration of MasterControl's eQMS platform, Manufacturing Excellence (Mx), LogBooks, and electronic Batch Records solutions for regulated industries.
- A3P AssociationminorProfessional organization membership providing access to industry trends, networking, and knowledge sharing in pharmaceutical manufacturing and quality management.
- SOFAQminorProfessional organization membership for quality and regulatory professionals in regulated industries.
- POLEPHARMAminorProfessional organization in the pharmaceutical sector providing industry networking and collaboration opportunities.
- TIC-SANTÉminorProfessional organization for digital health and IT in healthcare sector.
- ALLIS-NAminorProfessional organization providing networking and industry collaboration for life sciences professionals.
Scale indicators3 records
Recent moves7 records
Expansion highlights5 records
Apsalys competitors and assessment
Company assessmentBroad incumbents
- IQVIA: Largest CRO with an established regulatory affairs, quality compliance, and technology services practice — competes with Apsalys for compliance/regulatory work and has the scale to bundle multi-country programs that Apsalys cannot match.
- Veeva Systems: Large, publicly traded life sciences software company whose Vault Quality, Vault Training, and Vault Submissions suites overlap directly with the MasterControl modules Apsalys sells; a much larger incumbent with global enterprise reach.
- NSF International: Global testing, inspection, and certification body with a medical devices and pharma regulatory services practice that overlaps with Apsalys's audit, ISO 13485, and EU MDR compliance offerings at substantially larger scale.
- TÜV SÜD: Major international certification body providing ISO 13485, MDR, MDSAP, and pharmaceutical quality audits; competes with Apsalys's audit services for the same regulated-industry buyers across Europe.
Direct peers
- ComplianceQuest: QMS software vendor built natively on Salesforce, competing head-to-head with MasterControl in regulated eQMS, eBR, and supplier management for life sciences manufacturers — a direct alternative Apsalys's prospects may evaluate.
- BIA Consultores: Spanish MasterControl implementation partner serving Iberian and Latin American clients with QMS deployment, validation, and regulatory support — the same MasterControl-reseller-plus-services playbook Apsalys runs for francophone markets.
- Greenlight Guru: Medical device-focused QMS software vendor that competes directly with the MasterControl eQMS stack Apsalys distributes; targets the same ISO 13485 / MDR buyer in mid-market medtech with a SaaS-only go-to-market.
- 4C Partners: Belgian/Dutch consultancy and MasterControl implementation partner that operates an essentially identical business model to Apsalys — distributing and integrating the MasterControl platform while providing QMS, validation, and regulatory consulting — making it the cleanest architectural twin outside the francophone territory.
- USDM Life Sciences: US-headquartered MasterControl partner offering regulatory, quality, and validation services plus MasterControl implementation to life sciences companies; closely mirrors Apsalys's combined software-distribution-plus-consulting model.
- Techtransfer Advisers: Italian MasterControl implementation partner providing QMS, regulatory, and CSV consulting to pharma and medical device manufacturers; a regional peer with the same partner-with-MasterControl business model.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Apsalys social profiles
Digital presenceApsalys compliance and trust
Trust signalCompliance8 records
Apsalys financial estimates
Financial estimateRevenue estimate
Valuation estimate
Apsalys leadership team
Management profileNumber of profiles
Profiles7 records
Apsalys funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Apsalys 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 Apsalys
What does Apsalys do?
Apsalys is the exclusive official distributor and integrator of the MasterControl SaaS platform for French-speaking countries, specializing in electronic Quality Management (eQMS), Manufacturing Excellence with electronic batch records, LogBooks, and AQEM for life sciences and regulated industries. The company complements the platform with professional consulting services including QMS implementation, internal and supplier audits, regulatory affairs support (CE marking, MDR compliance, post-market surveillance), and Computerized System Validation aligned to FDA 21 CFR Part 11, EU MDR, ISO 13485, and GxP frameworks.
Is Apsalys a public or private company?
Apsalys is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Apsalys founded?
Apsalys was founded in 2004. It employs 1 to 10 people.
Where is Apsalys based?
Apsalys is headquartered in Asnières-sur-vègre, France, in the Europe region.
How does Apsalys make money?
Two revenue lines are on record. MasterControl Software Distribution and Integration is the primary driver. The others are consulting Services.
Who are Apsalys's main competitors?
Broad incumbents on record are IQVIA, Veeva Systems, NSF International and TÜV SÜD. Direct peers are ComplianceQuest, BIA Consultores, Greenlight Guru, 4C Partners, USDM Life Sciences and Techtransfer Advisers.
Does Apsalys have an API?
No public API is recorded for Apsalys.
What industry is Apsalys in?
Apsalys's product category is Life Sciences Regulatory & Quality Consulting. Its primary akta.pro industry code is HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight), with a secondary code of HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management). Its NAICS code is 54169 and its SIC code is 8731.