Clariscience

What Clariscience does

Clariscience (legal entity CLARISCIENCE SRL) is an Italian professional services consultancy founded in 2013 and headquartered in Padua, with a registered office in Milan. It serves the life sciences sector through three core service lines: Regulatory Affairs (technical documentation, MDR/IVDR gap analysis, device classification, risk analysis, clinical evaluations and PMCF, SSCP preparation, advertising authorization, and Notified Body interaction), Quality Management Systems (ISO 13485 implementation, QMS documentation, process validation, and internal/MDSAP/supplier/certification audits), and Medical Writing and Scientific Communication (clinical and medical writing, data analysis, visual communication, congress communication, advisory board support, scientific content creation, and training). Its customer base spans medical device manufacturers, IVD companies, pharmaceutical companies, cosmetics, nutraceutical/food supplement producers, veterinary device manufacturers, and manufacturers of MDR Annex XVI non-medical-purpose products.

The company operates a knowledge-based service model with no proprietary software or platform technology; its differentiation rests on cross-functional teams combining certified EMWA medical writers, ISO 9001 and ISO 13485 lead auditors, and regulatory affairs specialists. Its revenue is generated through project-based professional services engagements sold via consultative, sales-led B2B motion. Pricing is not publicly disclosed and engagements are customized to project scope rather than offered in standardized tiers.

Go-to-market relies on content marketing (a weekly "News&Stories" blog/magazine), a Mailchimp email newsletter, organic social presence on LinkedIn, Facebook, and Instagram, and SEO across Italian and English website versions. Customers reach the firm through website contact forms and direct outreach. The company is a privately held Società a Responsabilità Limitata with 1–10 employees, no identified institutional investors, parent company, or funding rounds, and appears independently owned and operated, serving primarily Italian and broader European clients.

Name

Clariscience

Legal name

CLARISCIENCE SRL

Website

https://clariscience.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

Clariscience is an Italian consultancy providing regulatory affairs, quality management systems (ISO 13485), and medical writing/scientific communication services to medical device, IVD, pharmaceutical, cosmetics, nutraceutical, and veterinary device companies across Italy and Europe under EU MDR/IVDR frameworks.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Medical Writing & Clinical Documentation FSP (HLAGAOAC), Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE)

Keywords

• Regulatory affairs consulting
• Medical device compliance
• Quality management systems
• Medical writing services
• IVDR compliance

Headquarters

HQ city

Padova

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs Consulting: Project-based consulting engagements for regulatory compliance, technical documentation, clinical evaluations, PMS support, and regulatory training for medical devices and IVDs under EU MDR and IVDR.
2. Quality Management Systems Consulting: ISO 13485 implementation, gap analysis, QMS documentation, internal audits, MDSAP audits, supplier audits, and certification audit preparation services.
3. Medical Writing and Scientific Communication: Clinical writing, medical writing, data analysis, visual communication, congress communication, advisory board support, and scientific content creation for the life sciences industry.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Clariscience is an Italian consulting firm providing three integrated service lines to life sciences companies: Regulatory Affairs (technical documentation, MDR/IVDR compliance, clinical evaluations, PMCF, SSCP), Quality Management Systems (ISO 13485 implementation, gap analysis, auditing, distributor/Importer compliance), and Medical Writing & Scientific Communication (clinical writing, congress communication, visual communication, advisory boards). Services are delivered to manufacturers, distributors, and importers of medical devices, IVDs, pharmaceuticals, cosmetics, nutraceuticals, and veterinary devices across Italy and Europe.

Product overview

Clariscience is a consulting services company providing three core service lines: Regulatory Affairs (Affari Regolatori), Quality Management Systems (Sistemi di Gestione per la Qualità), and Medical Writing and Scientific Communication (Medical Writing e Comunicazione Scientifica). The Regulatory Affairs division handles technical documentation, gap analysis for MDR/IVDR compliance, clinical evaluations, PMCF, SSCP preparation, and regulatory support including advertising authorization and Notified Body interaction. The Quality Management Systems service covers QMS implementation, gap analysis, process validation, auditing, and consulting for distributors and importers. The Medical Writing and Scientific Communication service includes medical writing, clinical writing, data analysis, visual communication tools, congress communication, advisory boards support, and scientific content creation. Services span medical devices, IVDs, pharmaceuticals, cosmetics, nutraceuticals, and veterinary devices sectors.

Differentiator

Problem solved

Functional benefit

Products and services

• Affari Regolatori (Regulatory Affairs) Comprehensive regulatory affairs consulting including technical documentation preparation, gap analysis for MDR and IVDR compliance, classification services, risk analysis, PMS support, and regulatory helpdesk for medical device and IVD manufacturers, distributors, and importers.
• Sistemi di Gestione per la Qualità (Quality Management Systems) Quality management system implementation and maintenance services including QMS documentation preparation, gap analysis from Directive to Regulation, ISO 13485 gap analysis, process validation, and consulting for distributors and importers of medical devices and IVDs.
• Medical Writing e Comunicazione Scientifica (Medical Writing and Scientific Communication) Scientific communication services including medical writing, clinical writing, data analysis, visual communication, congress communication, advisory board support, and customized training for the pharmaceutical and medical device industry.

Segments7 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Scale indicators1 record

Recent moves4 records

Expansion highlights4 records

Direct peers

• PharmaLex (Cencora): Regulatory affairs, quality, and medical writing consultancy (now part of Cencora) serving pharma and medtech — closely aligned service mix targeting the same European life sciences buyer.
• RQM+: Medical device regulatory and quality consulting firm (formerly R&Q) providing MDR/IVDR remediation, QMS, and post-market services to global medtech clients — competing head-to-head in the same regulatory/QMS niche.
• NAMSA: Medical device-focused contract research organization offering regulatory, quality, clinical, and laboratory services — overlapping with Clariscience across medical device regulatory affairs and quality management.
• Medidee: Swiss medical device regulatory and quality consulting firm offering MDR/IVDR compliance, clinical evaluations, and QMS support to European medtech manufacturers — highly comparable in scope and customer profile.
• Prova Health: Medical writing and scientific communications consultancy serving pharma and medical device companies — directly comparable to Clariscience's Medical Writing & Scientific Communication service line.
• Qserve Group: Dutch-headquartered consultancy specializing in EU MDR/IVDR regulatory affairs, quality management, and clinical evaluation services for medical device manufacturers — directly overlapping with Clariscience's core Regulatory Affairs and QMS service lines.

Broad incumbents

• ICON plc: Global CRO with regulatory, medical writing, and quality services across pharma and medtech — overlaps with Clariscience's regulatory and writing offerings as part of a much larger portfolio.
• Parexel International: Large global CRO offering regulatory affairs, medical writing, and clinical services across pharma and medical devices — competes for the same regulatory consulting wallet but from a global full-service scale.
• IQVIA: Global clinical and regulatory services provider with extensive medical writing and regulatory affairs capabilities serving life sciences manufacturers — a broader, scaled competitor in adjacent service lines.
• BSI Group: UK-based standards body and Notified Body providing ISO 13485 certification, regulatory compliance consulting, and medical device testing — addresses the same EU medtech regulatory buyer but at much greater scale and breadth.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/clariscience
• LinkedInlinkedin.com/company/clariscience
• Instagraminstagram.com/clariscience

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

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 Clariscience