What Biokosmes does

Biokosmes s.r.l. is an Italian Contract Development and Manufacturing Organization (CDMO) specialising in the development and production of topical products for the medical device and cosmetics industries. Headquartered in Bosisio Parini (province of Lecco, near Milan), the company operates 20+ filling lines, employs 100+ staff, and claims more than 40 years of accumulated experience across formulation R&D, regulatory affairs, and manufacturing. Its service portfolio covers the full project lifecycle — from product concept definition and formula development through regulatory support to final packaging — and it also offers a white-label catalogue of ready-to-market medical devices across more than 10 therapeutic areas. In-house technical infrastructure includes climatic chambers for stability studies and a microbiological analysis laboratory, both operated without external dependency.

The company serves two principal customer segments on a B2B basis: medical device manufacturers requiring CE-marked production (Class IIa, IIb, and III) with full technical documentation and post-market surveillance support, and cosmetics and skin-care brands requiring CPNP notification and compliance with EU Regulation 1223/2009. Biokosmes operates a sales-led go-to-market motion, with direct client engagement via a website contact form that captures target market, target cost, and annual volume, supplemented by a LinkedIn presence. It is differentiated by an unusually broad regulatory certification stack — ISO 13485, ISO 9001, ISO 22716, MDSAP, BRCGS Grade AA, FDA Registration, Health Canada CMDCAS, ANVISA, Japan MHLW, Australian TGA, Israeli MoH, UAE MoH, Korean FDA, Mexican MoH, and Halal — that allows it to ship from a single Italian site into most major regulated markets.

Since 2025 Biokosmes has operated as a member of the Healthea Group, a newly formed consortium consolidating leading European healthcare CDMOs under a single brand, with factories primarily in Italy covering a wide range of galenic forms. The legal entity remains a privately held Italian s.r.l. subject to direction and coordination by Biodue S.p.A. pursuant to Italian Civil Code Article 2497 bis. The company has no public funding history, no disclosed revenue, no named customers, and no disclosed management team, and it has invested in a formal sustainability program since 2022 that produced an EcoVadis Silver Medal (Top 15%) in 2024.

Name

Biokosmes

Legal name

Biokosmes s.r.l.

Website

https://biokosmes.it

Company type

Private

Founded year

2017

Operating status

Operating

Short description

Biokosmes s.r.l. is an Italian CDMO providing full-service contract development and manufacturing of topical medical devices (Class IIa-IIb-III) and cosmetics for global B2B clients, operating from Bosisio Parini with 100+ staff, 20+ filling lines, and 40+ international certifications.

Ownership category

akta.pro rank

Headquarters

HQ city

Bosisio Parini

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services: Full-service CDMO providing development and production of medical devices and cosmetics. Services span from concept definition to formula development and final packaging. Supports both full service engagements and subcontracting of specific components.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Biokosmes is an Italian Contract Development and Manufacturing Organization (CDMO) that provides full-service contract manufacturing for medical devices (Class IIa, IIb, and III) and cosmetics. The company supports clients from product concept definition through formula development, regulatory affairs, and final packaging, operating with in-house climatic chambers, microbiological analysis, and 20+ filling lines.

Product overview

Biokosmes is an Italian Contract Development and Manufacturing Organization (CDMO) offering a 360-degree partner approach for the development and production of medical devices and cosmetics. The company operates as a unified service platform combining three core product categories: medical devices manufacturing (Class IIa, IIb, III) and cosmetics manufacturing as the primary offerings, supported by Regulatory Affairs Services and Research & Development services as integrated modules. Additionally, the company offers White Label ready-to-market products in medical devices across over 10 therapeutic areas. With over 40 years of experience, 20+ filling lines, and more than 100 staff members, the company provides full-service support from concept definition to formula development and final packaging.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Devices Manufacturing Contract development and manufacturing of medical devices (Class IIa, IIb, and III) for the European and global markets, including topical products and devices across over 10 therapeutic areas, with support for CE certification, technical documentation, and post-market surveillance.
• Cosmetics Manufacturing
• Regulatory Affairs Services
• Research & Development Services
• White Label Products

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Healthea GroupparentStrategic or Co-development Partner · 1 January 2025Biokosmes is part of the Healthea Group, founded in 2025 with the aim of bringing together under a single brand the best CDMOs in Europe. The group provides one of the widest commercial offers in the healthcare sector on the European market. Healthea Group has factories mainly in Italy, capable of producing almost all galenic forms and product categories of the healthcare sector, including medical devices in over 10 therapeutic areas and a wide list of ready-to-market products in white label.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Recipharm: Global CDMO offering development and manufacturing services for pharmaceuticals and certain medical device combination products across multiple European and U.S. sites. Comparable contract manufacturing footprint and regulatory infrastructure, though Recipharm does not emphasize cosmetics the way Biokosmes does.
• Aenova Group: European-headquartered CDMO with multiple sites producing solid, semi-solid, and sterile dosage forms including topicals for pharma and cosmetics. Comparable as a full-service contract manufacturer serving brand and MedTech customers across regulated markets, though Aenova operates at materially larger scale than Biokosmes.
• Fareva Group: French-headquartered CDMO with dedicated cosmetics and pharmaceutical manufacturing divisions across Europe. Highly comparable as a multi-site European contract manufacturer serving beauty and healthcare brands with topical and personal-care products.
• Menarini Group (Manufacturing operations): Italian pharmaceutical group with substantial in-house manufacturing of topicals, dermatology, and medical devices. Comparable as an Italian-headquartered manufacturer of regulated topical products, though Menarini is largely proprietary rather than a pure CDMO.
• Recordati (Dermatology / Topicals): Italian-headquartered specialty pharma group with significant dermatology and topical manufacturing operations. Comparable as another established Italian manufacturer of topical regulated products with international distribution.
• Cosmo Pharmaceuticals: Italian specialty pharmaceutical manufacturer with topical and dermatology products across European and U.S. markets. Comparable regulated-manufacturing capability in topicals, though Cosmo is brand-owner-led rather than a dedicated CDMO.

Direct peers

• Intercos Group: Italian-headquartered contract manufacturer specializing in color cosmetics and skincare products for global beauty brands. Comparable contract development and manufacturing model for cosmetics and skin care, with overlapping customer base of European beauty brands.
• Fine Foods & Pharmaceuticals NTM: Italian CDMO specialized in contract development and manufacturing of cosmetics, medical devices, and dietary supplements including topical formulations. The closest direct peer on geography and topical CDMO scope, competing for the same Italian and European brand customers.

Others

• Bormioli Pharma: Italian supplier of primary packaging (bottles, closures, devices) for pharmaceutical and medical-device manufacturers. Comparable Italian healthcare manufacturing ecosystem player and ecosystem enabler for topical CDMO customers, though focused on packaging components rather than formulation.

Emerging players

• Laboratoires Farmaceutiques STERILGO (Sterilgo): European contract manufacturer focused on sterile and aseptic filling for medical devices and combination products. Comparable specialized filling-line capability for regulated medical-device customers, though at smaller scale and more focused on sterile injectables than topicals.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/biokosmes

Compliance16 records

Revenue estimate

Valuation estimate

Number of profiles

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 Biokosmes