What Biorius does

Biorius is a Wavre, Belgium-headquartered cosmetic regulatory services and technology firm founded in 2008, specializing in helping beauty, personal care, and adjacent FMCG brands achieve and maintain regulatory compliance across multiple jurisdictions including the EU, UK, US, and other markets. The firm operates as the legally appointed Responsible Person (RP) for client products, performing safety assessments, CPNP notifications, label and claims reviews, and ongoing post-market surveillance. It reports a customer base of 1,500+ cosmetic brands across 60+ countries, with a cumulative track record of evaluating 50,000+ products against a proprietary curated database of 14,000+ raw materials.

The company monetizes through a mix of fee-for-service regulatory projects (RP mandates, product safety dossiers, compliance audits), recurring subscription access to its MyApps software platform (which handles formula checks, label compliance, claims substantiation, and reporting), and ancillary certification and laboratory testing services. Notable product launches include Biorius Watch in 2025 — a continuous regulatory monitoring and predictive alert product — and a free-tier MyApps Data Exchange aimed at ingredient suppliers and emerging brands. The firm also operates a Preferred Manufacturer partnership program that connects brand clients with vetted contract manufacturers, extending its role beyond pure regulatory advisory into the broader brand launch value chain.

Biorius employs 50-100 specialists spanning toxicology, chemistry, regulatory affairs, and software development, with a US subsidiary (Biorius Inc.) supporting North American clients entering EU/UK markets. Named customer logos include brands such as Rare Beauty, Manscaped, and Hourglass across skincare, hair care, color cosmetics, personal care, and sun care categories, with the firm additionally extending services into detergents, candles, and biocidal products. The firm's core commercial logic is to convert episodic regulatory projects into durable, multi-year relationships by being the single legal point of accountability for product safety in regulated markets.

Name

Biorius

Legal name

Biorius SPRL

Website

https://biorius.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Short description

Biorius is a Belgium-headquartered cosmetic regulatory services and technology firm, founded in 2008, providing Responsible Person mandates, compliance software (MyApps, Biorius Watch), and certification/testing services to 1,500+ beauty and personal care brands across 60+ countries.

Ownership category

akta.pro rank

Product category

Cosmetic Regulatory Consulting

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Intelligence, Labeling & Promotional Compliance (HLAGAKAN)

akta.pro secondary industry

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

Keywords

• Cosmetic regulatory consulting
• Responsible person services
• Cosmetic product compliance
• Regulatory software platform
• Cosmetic safety assessment

Headquarters

HQ city

Wavre

HQ country

Belgium

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Regulatory Consulting Services: Professional consulting services including cosmetic product safety assessments (CPSR), formula reviews, label reviews, PIF preparation, and regulatory compliance verification. Provided by in-house toxicologists, regulatory experts, pharmacists, and chemists.
2. Legal Representation Services: Acting as Responsible Person (RP) for brands in EU, UK, USA, and Canada markets. Represents and defends brands to local authorities, manages regulatory compliance, handles customer complaints, and manages undesirable effects reporting.
3. Cosmetic Certifications: Certification services including Vegan, Natural and Organic, Gluten-Free, Soy-Free, and GMO-Free certifications. These certifications are recognized worldwide, valid without renewal, and include logos for marketing use.
4. MyApps Software Platform: Free Data Exchange module for all clients with unlimited usage. The platform serves as an Electronic Document Management System for products and raw materials. Additional premium features available.
5. Laboratory Testing Services: Facilitates lab testing including stability testing, challenge testing, microbiological testing, efficacy testing, SPF testing, and safety testing through partner laboratories.
6. Registration Solutions: Market access registration services for 60+ countries including EU, UK, US, Canada, China, Japan, South Korea, Taiwan, ASEAN, Australia, Brazil, South Africa, and others.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Biorius provides cosmetic regulatory consulting and compliance services to cosmetic brands, manufacturers, and importers, enabling them to sell products in the EU, UK, US, Canada, and 60+ international markets. The company's offerings include Responsible Person legal representation, product safety assessments (CPSR), formula and label reviews, PIF preparation, and international market registration. Its proprietary MyApps platform and Biorius Watch regulatory intelligence system automate and centralize regulatory document management, formula tracking, and real-time regulatory monitoring.

Product overview

Biorius is a cosmetic regulatory consulting firm offering a unified portfolio of regulatory, toxicology, and certification services. The core technology products are Biorius MyApps (the primary regulatory management software platform) and Biorius Watch (regulatory intelligence and formula screening). These are complemented by a comprehensive suite of service offerings including EU/UK/US/Canada Responsible Person services, cosmetic compliance consulting, laboratory testing, product certifications (vegan, natural/organic, gluten-free, GMO-free), international market registration (60+ countries), REACH services, and additional regulatory support (GPSR, detergents, candles, SDS). The MyApps platform serves as the central hub for document management, formula tracking, and regulatory submissions, while Biorius Watch provides proactive regulatory monitoring and predictive alerts.

Differentiator

Problem solved

Functional benefit

Brands

• MyApps: In-house regulatory management software platform that streamlines product regulatory studies, document management, and compliance tracking for cosmetic companies.
• Biorius Watch

Products and services

• Biorius MyApps Core cosmetic regulatory software platform that streamlines the entire regulatory study process for cosmetic brands and manufacturers. Provides centralized document storage, raw materials database with 14,000+ entries, ingredients lists management, project management, automated PIF generation, multi-shade product management, automated document checks, and two-factor authentication security.
• Biorius Watch Regulatory intelligence solution that continuously screens cosmetic formulas against real and upcoming regulatory changes, delivering predictive product impact assessments and expert recommendations for cosmetic brands and manufacturers.
• EU & UK Responsible Person Services Legal representation services ensuring cosmetic products comply with EU Cosmetics Regulation (EC No 1223/2009) and UK Cosmetics Products Enforcement Regulations 2013. Biorius acts as point of contact with local authorities during inspections, and with consumers in case of issues.
• MoCRA US Agent Services Legal representation and US Agent services for MoCRA (Modernization of Cosmetics Regulation Act) compliance for cosmetic brands selling in the US market. Includes formula review, safety substantiation reports, cosmetic product listing, and state-specific provisions compliance.
• Canada Responsible Person Services Legal representation services for cosmetic product compliance in the Canadian market. Biorius acts as the local Responsible Person for brands selling cosmetic products in Canada.
• Cosmetic Regulatory Compliance Services Comprehensive compliance consulting services including Formula Review, Cosmetic Product Safety Reports (CPSR) Parts A&B, Label and Claims Review, Product Information File (PIF) Preparation, and CPNP/SCPN Notifications for EU/UK markets. US services include MoCRA formula review, label and claims review, safety substantiation reports, cosmetic product listing, and state-specific provisions.
• Cosmetic Certifications Third-party certification services for cosmetic products including Vegan Certification, Natural and Organic Certifications, Gluten-Free Certification, Soy-Free Certification, and GMO-Free Certification. Certifications are globally recognized, valid without renewal, and include logos for marketing use on packaging.
• Laboratory Testing Services Laboratory testing services for cosmetic products including Stability Testing, Challenge Testing (Preservation Efficacy), Microbiological Testing, Efficacy Testing, SPF Testing, and Safety Testing, facilitated through partner laboratories.
• International Market Registration Market access registration services for cosmetic products in over 60 international markets including Canada, Taiwan, Australia, Japan, South Korea, China, ASEAN, South Africa, Brazil (MERCOSUR), Andean Community (CAN), and Middle East regions.
• REACH Services for Cosmetics REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) compliance services specifically tailored for the cosmetics industry.
• Additional Regulatory Services Additional regulatory compliance services including General Product Safety Regulation (GPSR), Detergent Regulation, EU Candle Regulations, Poison Centre Notification (PCN), and Safety Data Sheet (SDS) preparation.

Quantifiable outcome

• Evaluated 50,000+ products with successful compliance management over 15 years
• +2 more outcomes

Named customers26 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature7 records

Partnerships

Eleven partnerships are on record, tiered minor and core.

• Independent Beauty (IBA)minorOthersIndustry association membership providing networking, industry advocacy, and regulatory guidance for the beauty and cosmetics industry.
• Personal Care CouncilminorOthersIndustry association representing personal care products sector, providing regulatory advocacy and industry standards development.
• Cosmetics EuropeminorOthersLeading European cosmetics industry association representing the interests of cosmetic manufacturers and ensuring regulatory compliance guidance.
• CosmedminorOthersFrench cosmetics industry association providing regulatory support and industry networking for member companies.
• DeticminorOthersBelgian industry association for detergents and cosmetic products, providing regulatory guidance and industry representation.
• ERPA (European Responsible Person Association)coreOthersAssociation specifically for Responsible Persons in the cosmetics industry, providing best practices, regulatory updates, and professional standards for RP services.
• 220labsminorStrategic or Co-development PartnerRecommended hair, skin & body care contract manufacturer through Biorius Preferred Manufacturer's Program. Helps cosmetic brands find reliable manufacturing partners.
• CovalenceminorStrategic or Co-development PartnerRecommended drug & personal care contract manufacturer through Biorius Preferred Manufacturer's Program.
• Marianna BeautyminorStrategic or Co-development PartnerRecommended hair & skincare contract manufacturer through Biorius Preferred Manufacturer's Program.
• KDC ONEminorStrategic or Co-development PartnerRecommended beauty, personal care & household cleaning contract manufacturer through Biorius Preferred Manufacturer's Program.
• ACT LaboratoriesminorStrategic or Co-development PartnerRecommended safety & compliance testing laboratory through Biorius Preferred Manufacturer's Program.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• CE.way: Slovenia-based cosmetic regulatory consultancy offering Responsible Person services in the EU/UK and multi-country registration support. Direct competitor for Biorius's core EU/UK RP franchise and very similar customer base of cosmetic brands and manufacturers.
• Cosmetic Compliance (CRC / Cosmetic Regulatory Compliance): Specialized US/EU cosmetic regulatory consulting firm providing MoCRA US Agent, EU Responsible Person, formula and label review. Directly comparable service portfolio to Biorius, particularly for North American cross-border compliance work.
• Personal Care Regulatory Ltd: UK-based regulatory consultancy focused on cosmetic and personal care compliance, including Responsible Person services and product safety assessments. Competes head-to-head with Biorius in the UK and EU markets for indie and mid-market brand clients.

Broad incumbents

• Intertek: Global testing, inspection and certification giant with established cosmetic regulatory and lab testing services. Competes with Biorius in lab testing and adjacent regulatory services, though cosmetics are a smaller slice of its much broader portfolio.
• SGS: World's largest testing, inspection and certification company offering cosmetic product safety, regulatory and lab testing services. Overlaps with Biorius in cosmetic testing and regulatory support but is diversified across many industries and geographies.
• Eurofins: International group of laboratories providing cosmetic testing, safety assessment and regulatory support across multiple jurisdictions. Competes with Biorius in lab testing and toxicology, with much broader life sciences testing scale.
• Bureau Veritas: Global testing, inspection and certification company with consumer products and cosmetics testing capabilities. Overlaps with Biorius's lab testing and compliance offerings as part of a much wider TIC portfolio.
• Charles River Laboratories: Major CRO with safety assessment capabilities used by cosmetic and personal care companies. Adjacent to Biorius in toxicology and safety substantiation, though its core franchise is pharmaceutical preclinical rather than cosmetic regulatory.

Emerging players

• MSL Solution Providers: UK-based regulatory and quality compliance consultancy offering cosmetic and consumer product services, including UK/EU Responsible Person. Competes with Biorius in UK/EU RP and cosmetic compliance, particularly for smaller brands.
• Cosmetic Solutions (COS Solutions): Cosmetic regulatory consultancy providing global registration, safety assessment and product notification services. Comparable to Biorius for international market access work and CPSR/PIF preparation, though smaller in scale and geographic coverage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biorius-sprl
• Xx.com/Biorius

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biorius