Donawa Lifescience

What Donawa Lifescience does

Donawa Lifescience Consulting Srl is a privately held, full-service Contract Research Organization (CRO) and regulatory consultancy founded in 2006 and headquartered in Rome, Italy, with a wholly owned US subsidiary (Donawa Lifescience, Inc., Cambridge, Massachusetts). The firm is purpose-built around the regulatory and clinical lifecycle of medical devices, in vitro diagnostics (IVDs), and combination products in the EU and US markets, operating across four service lines: (1) CRO Services for full-service clinical study management spanning study planning, conduct, and regulatory submission in the EU, US, and Canada; (2) Regulatory and Ethics Submissions, including CRO-led authority and ethics-committee filings; (3) Regulatory and Quality consulting for EU MDR and US FDA system issues; and (4) Clinical Evaluation, producing MDR- and Notified Body-aligned clinical evaluation plans, reports, and equivalence determinations. The firm runs no proprietary software or platform-as-a-service product; its delivery model is professional-services based on bespoke, project-specific engagements, sold directly by its senior team.

The firm's commercial engine is direct enterprise sales to medical device and IVD manufacturers needing CE marking under MDR/IVDR, FDA 510(k)/De Novo/PMA pathways, or clinical investigation support, with secondary emphasis on Chinese medical-device exporters seeking EU access. Notable delivered outcomes include clinical study management for PainChek Ltd's FDA De Novo clearance (DEN240073, November 2025) across 100+ US nursing-home patients and regulatory assistance to Tournicare Pty Ltd for the 510(k) clearance of the ARMA OTC Blood Pressure Monitor (June 2026). Marketing is content-led, leaning heavily on President Maria E. Donawa's LinkedIn 'Regulatory Recap' series, an extensive white-paper library, conference speaking at EAAR and RAPS, and packaged education products such as the October 2025 EU pre-market clinical investigations Masterclass. Distribution is single-channel: direct client engagement via phone, email, and web contact form, supplemented by partnerships with Clariscience (scientific communication) and Mediclever Reimbursement Consultants to round out a clinical-regulatory-reimbursement-communications value chain.

Name

Donawa Lifescience

Legal name

Donawa Lifescience Consulting Srl

Website

https://donawa.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Donawa Lifescience is a boutique EU-based CRO and regulatory consultancy, founded 2006 in Rome, providing clinical study management, regulatory submissions, and clinical evaluation services to medical device and IVD manufacturers seeking EU MDR and US FDA market access, with a Cambridge, Massachusetts US subsidiary.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) — Medical Devices & IVDs

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

Keywords

• Medical device CRO
• Clinical study management
• Regulatory submissions
• Clinical evaluation reports
• IVD compliance consulting

Headquarters

HQ city

Rome

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, Infrastructure, Others

Revenue model

1. CRO Services: Full-service clinical study management including study planning, conduct, and regulatory submissions for medical devices, IVDs, and combination products in EU, US and Canada.
2. Regulatory and Ethics Submissions: Regulatory and ethics committee submissions to minimize authority questions and streamline approvals for clinical programs.
3. Regulatory and Quality Consulting: Expert assistance with EU or US regulatory or quality system issues for all types of medical devices, including IVDs and combination products.
4. Clinical Evaluation: Development of MDR- and Notified Body-aligned clinical evaluation plans and reports to support regulatory review.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Donawa Lifescience is a full-service contract research organization (CRO) and regulatory consultancy that manages clinical studies and regulatory submissions for medical device, IVD, and combination product manufacturers. The firm provides four core service lines—CRO Services, Regulatory & Ethics Submissions, Regulatory and Quality, and Clinical Evaluation—covering study planning, conduct, regulatory authority and ethics committee submissions, quality system support, and MDR-aligned clinical evaluation plans and reports for EU, US, and Canadian markets.

Product overview

Donawa Lifescience is a full-service Contract Research Organization (CRO) and regulatory consultancy specializing in medical devices and in vitro diagnostics (IVDs) for the EU and US markets. The company offers an integrated portfolio of four core service lines: CRO Services for clinical study management, Regulatory & Ethics Submissions for regulatory and ethics committee submissions, Regulatory and Quality for regulatory and quality system support, and Clinical Evaluation for MDR-aligned clinical evaluation plans and reports. Services span from study planning through regulatory submission, supporting manufacturers seeking CE marking, FDA clearance/approval, and market access.

Differentiator

Problem solved

Functional benefit

Products and services

• CRO Services Full-service clinical study management aligned with EU and US regulatory expectations, covering study planning through conduct, designed to avoid delays, redesigns, and repeat studies for medical devices, IVDs, and combination products in the EU, US, and Canada. The service is intended for medical device and IVD manufacturers seeking clinical evidence to support CE marking and FDA clearance.
• Regulatory & Ethics Submissions CRO-led regulatory and ethics committee submissions for medical device and IVD clinical programs, including high-quality submissions to US and EU regulatory authorities, assistance with Ethics Committees, and negotiation of site agreements. Intended for manufacturers pursuing clinical investigations and regulatory approvals in EU and US.
• Regulatory and Quality Regulatory and quality system support for medical devices, IVDs, and combination products, providing early clarity on requirements and preventing late-stage compliance gaps and rework. Covers EU and US regulatory or quality system issues for all types of medical devices. Intended for medical device and IVD manufacturers.
• Clinical Evaluation Development of MDR- and Notified Body-aligned clinical evaluation plans and reports to support regulatory review and provide robust templates for future updates. Includes clinical evaluation reports (CERs), clinical data strategies, and determination of device equivalence. Intended for medical device manufacturers preparing CE marking under MDR.

Quantifiable outcome

• Successfully supported PainChek Ltd in achieving FDA De Novo clearance for world's first smart device-based pain assessment app
• +1 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Two partnerships are on record, tiered minor.

• ClariscienceminorStrategic or Co-development PartnerA full service scientific communication consultancy supporting companies, researchers and clinical professionals. Their team provides scientific, marketing and communication skills to support life science businesses by preparing optimum product test plans in support of regulatory submissions.
• Mediclever Reimbursement ConsultantsminorImplementation/ SI/ Consulting PartnerA reimbursement consulting firm helping life-science companies commercialize pharmaceuticals and medical devices worldwide. With over 30 reimbursement consultants throughout the USA and Europe and more than 150 clients worldwide, they provide full responsibility for reimbursement from early strategy to establishment of specific reimbursement codes, payment rates and favorable coverage.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• IQVIA: Largest global CRO with broad medical device clinical and regulatory capabilities. Competes with Donawa on enterprise device sponsor RFPs and has been actively expanding its medtech CRO offerings.
• ICON plc: Global CRO with dedicated medical device and combination product services post-PRA Health Sciences and other acquisitions. Overlaps with Donawa on device clinical operations and regulatory submissions at much larger scale.
• PharmaLex (now part of Cencora): Regulatory and development services provider with a medical device practice alongside pharma. Competes with Donawa on EU/US regulatory submissions, clinical strategy and quality for device manufacturers.
• Medpace: Mid-to-large global CRO with a dedicated medical device and diagnostics clinical operations group. Overlaps with Donawa on device clinical trial management but operates at meaningfully greater scale across many therapeutic areas.

Direct peers

• NAMSA: The largest pure-play medical device CRO, offering preclinical, clinical, regulatory and quality services globally. NAMSA is the closest direct competitor to Donawa in the device-focused CRO category, but at significantly larger scale.
• Maetrics: Device and IVD regulatory affairs and quality assurance consultancy with EU and US presence. Competes with Donawa on regulatory strategy, submissions and quality system remediation for medical device manufacturers.
• RQM+: MedTech-focused regulatory, quality and clinical services firm serving device manufacturers across EU and US. Directly competes with Donawa on regulatory submissions, CERs and quality system support for device companies.
• Qserve Group: European-headquartered CRO and regulatory consultancy specializing in medical devices and IVDs, with deep MDR expertise. Closely comparable to Donawa in niche, geographic roots and service mix (clinical, regulatory, quality).

Others

• TÜV SÜD: Major Notified Body and testing/certification organization for medical devices and IVDs. Adjacent ecosystem participant to Donawa's regulatory and clinical evaluation work rather than a direct competitor.
• BSI Group (Notified Body): Notified Body for medical devices and IVDs in the EU. Not a direct competitor but a key ecosystem participant: Donawa prepares CERs and submissions that BSI reviews, and Dr. Donawa has authored a BSI Compliance Navigator white paper.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/profile.php
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Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

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 Donawa Lifescience