Clinpharma

What Clinpharma does

Clinpharma S.r.l. is an Italian boutique pharmaceutical consulting firm founded in 2014 by Viola Di Marco and Fabiana Auricchio, headquartered in Somma Vesuviana (Naples), with a registered office in S. Sebastiano al Vesuvio. The company provides specialized consulting services across pharmacovigilance, regulatory affairs, medical direction, market access, and quality systems for pharmaceutical, medical device, cosmetics, and food supplement companies operating primarily in Italy and Europe. Both founders hold Qualified Person Responsible for Pharmacovigilance (QPPV) certifications and serve as embedded Responsible Persons across multiple client organizations, with the firm positioned as a single-source provider for EU and Italian regulatory compliance.

The company's service portfolio is organized under four divisions: Clinpharma Pharmacovigilance & Regulatory Affairs (the original core, covering pre- and post-marketing pharmacovigilance, eCTD dossier preparation, AIFA submissions, medical device vigilance under MDR 2017/745, and quality systems including GxP and ISO 13485); Clinpharma Academy (continuous education and a Level II Master's program in partnership with the University of Campania 'Luigi Vanvitelli'); Clinpharma Market & Value Access (pricing/reimbursement dossier preparation and AIFA negotiation support); and Clinpharma for Business (budget modeling, KPI dashboards, project management, and temporary management). Underlying technology consists of validated pharmacovigilance databases, eCTD document management systems, and the EudraVigilance/XEVMPD reporting infrastructure mandated by European regulators — these are standard regulatory tools rather than proprietary platforms.

Clinpharma operates on a professional services revenue model, charging project-based or retainer fees for full-service outsourcing (e.g., serving as the client's QPPV) or on-demand consulting engagements. Go-to-market is sales-led via direct B2B outreach, professional network referrals, the Academy's training programs as a mid-funnel channel, and founder-led industry presence through LinkedIn and organizations such as SIF, SIARV, Farmindustria, and PIPA. The firm is founder-owned with no disclosed external institutional or venture capital investment, no public listing, and an 11-50 employee headcount consistent with a specialized boutique consultancy.

Name

Clinpharma

Legal name

Clinpharma Srl

Website

https://clinpharma.it

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Clinpharma is an Italian boutique consulting firm providing pharmacovigilance, regulatory affairs, market access, and training services to pharmaceutical, medical device, cosmetics, and food supplement companies in Italy and Europe. Founded in 2014, the founder-led firm serves as embedded QPPV and regulatory partner for clients navigating EU and AIFA compliance.

Ownership category

akta.pro rank

Product category

Pharmaceutical Consulting Services

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169), Other Management Consulting Services (541618)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

akta.pro secondary industries

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Pharmacovigilance consulting
• Regulatory affairs services
• Drug safety monitoring
• Medical device compliance
• Market access strategy

Headquarters

HQ city

Somma Vesuviana

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

Revenue model

1. Pharmacovigilance Consulting Services: Full-service or on-demand outsourcing of pharmacovigilance activities for pharmaceutical companies, including QPPV services, safety database management, ICSR submissions, signal management, PSUR/RMP preparation, and regulatory inspection support.
2. Regulatory Affairs Services: Regulatory consulting including dossier preparation in eCTD format, variations, AIFA submissions, and lifecycle management for pharmaceutical products.
3. Training and Academy Programs: Continuing education programs including pharmacovigilance training, GxP training, and a Master program partnership with University of Campania 'Luigi Vanvitelli'.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Clinpharma is a chemical-pharmaceutical consulting firm providing B2B pharmacovigilance and regulatory affairs services to pharmaceutical, medical device, cosmetics, and food supplement companies. It offers full-service outsourcing or on-demand consulting across pre- and post-marketing drug safety, eCTD regulatory dossier preparation and AIFA/EMA submissions, medical device vigilance, market access and pricing/reimbursement dossier preparation, GxP and ISO 13485 quality systems implementation, and continuing professional training through its Academy division.

Product overview

Clinpharma Group is a consultancy company providing comprehensive pharmaceutical consultancy services to companies in the chemical-pharmaceutical sector. The company operates through four main divisions: Clinpharma Pharmacovigilance & Regulatory Affairs (offering pharmacovigilance, regulatory affairs, medical direction, medical device vigilance, and scientific services); Clinpharma Academy (providing training courses and the Master in Farmacovigilanza program); Clinpharma Market & Value Access (covering market access and pricing/reimbursement strategies); and Clinpharma for Business (delivering business consulting including budget models, KPI dashboards, and project management). Services are delivered in compliance with current European and national regulations, offering both full-service and on-demand engagement models.

Differentiator

Problem solved

Functional benefit

Brands

• Clinpharma Academy: Training division offering continuous education courses for pharmaceutical industry professionals, including a Master's program in Pharmacovigilance and Pharmacoepidemiology
• Clinpharma Market & Value Access
• Clinpharma for Business
• Clinpharma Pharmacovigilance & Regulatory Affairs

Products and services

• Clinpharma Pharmacovigilance & Regulatory Affairs Core division providing pharmacovigilance services (pre- and post-marketing for human and veterinary medicinal products, medical device vigilance, cosmetics and food supplements vigilance), medical direction and scientific services, quality systems (GxP and ISO 13485), regulatory affairs, and related services for pharmaceutical and medical device clients in Italy and Europe.
• Clinpharma Academy Educational and training division offering annual continuing-education programs and courses for pharmaceutical industry professionals seeking to deepen specialized topics or build professional growth foundations, including pharmacovigilance and GxP training.
• Clinpharma Market & Value Access Division supporting companies in evaluating commercial needs, achieving competitive positioning through market access strategies, preparing pricing and reimbursement dossiers, and negotiating prices with AIFA.
• Clinpharma for Business Division providing business consulting services including budget and forecast model construction, KPI dashboard creation, marketing and sales support, access and long-term strategy, project management, innovation management, organizational models, and temporary management.
• Farmacovigilanza (Pharmacovigilance) Complete outsourcing management of pharmacovigilance services for human and veterinary products and parallel import drugs, including QPPV, quality assurance, adverse drug reaction management, signal management, PSMF, PSUR, RMP, SUSAR handling, and regulatory submissions.
• Affari Regolatori (Regulatory Affairs) Regulatory affairs services covering European and extra-European regulatory matters including dossier preparation in eCTD format, submissions to AIFA and other agencies, variations, gap analysis, and lifecycle management.
• Direzione Medica e Medical Information Medical direction and medical information services including daily email monitoring, bibliographic research, scientific response preparation, translation, and reporting on medical inquiries.
• Medical Device, Cosmetici ed Integratori Alimentari Consultancy for medical devices, cosmetics, and food supplements including CE marking support, technical documentation, ISO 13485 quality systems, Eudamed database management, and post-market surveillance.
• Servizio Scientifico (Scientific Services) Scientific service office ensuring compliance with D.Lgs. 219/2006, including scientific service representative nomination, promotional material management, congress organization, and AIFA communication.
• Market Access e Dossier Prezzo e Rimborso Market access services including pricing evaluation, pricing and reimbursement dossier preparation, economic evaluations, AIFA e-dossier portal submission, and price negotiation.
• Master in Farmacovigilanza e Farmacoepidemiologia Level II university Master's program in Pharmacovigilance, Pharmacoepidemiology, and Regulatory Activities offered in partnership with Università degli Studi della Campania Luigi Vanvitelli, with Clinpharma as corporate partner.

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

One partnership is on record.

• University of Campania 'Luigi Vanvitelli' - Department of Experimental MedicinecoreStrategic or Co-development Partner · 1 January 2022Clinpharma serves as a corporate partner of the Master's program in 'Farmacovigilanza, farmacoepidemiologia ed attività regolatorie'. Managing Partner Fabiana Auricchio teaches modules on 'Quality Systems and Audit' and 'Periodic Safety Update Report (PSUR)'. This partnership provides academic legitimacy and access to emerging talent in the pharmacovigilance field.

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• TFS International: Global CRO with dedicated regulatory and pharmacovigilance services. Larger, broader incumbent competing for the same outsourced QPPV/RA mandates as Clinpharma.
• IQVIA: Global life-sciences services leader offering integrated pharmacovigilance, regulatory, and clinical research. Represents the scaled incumbent that boutiques like Clinpharma compete against on multinational RFPs.
• Worldwide Clinical Trials: Mid-sized global CRO with PV and regulatory affairs service lines. Comparable in offering PV/RA support but operates at meaningfully larger scale than Clinpharma.
• Parexel International: Large global CRO with dedicated regulatory and pharmacovigilance service lines. Competes with Clinpharma for outsourced PV/RA work from mid-size and large pharma sponsors.
• ICON plc: Global CRO offering pharmacovigilance, regulatory affairs, and clinical development services. Broad incumbent with overlapping PV/RA capabilities relative to Clinpharma's service portfolio.

Direct peers

• PharmaLex: Global regulatory, pharmacovigilance, and quality consulting firm (now part of Cencora). Comparable to Clinpharma in service scope (RA, PV, quality systems) but with broader geographic coverage.
• PrimeVigilance: Specialist pharmacovigilance and regulatory services CRO headquartered in Europe. Directly comparable to Clinpharma as a PV/RA-focused consultancy offering QPPV, PSUR/RMP, and signal management to pharma and device sponsors.
• Arriello: European life-sciences consultancy covering pharmacovigilance, regulatory affairs, and quality/compliance for pharma and medical-device companies. Closely mirrors Clinpharma's boutique PV/RA + MDR service model.
• ProductLife Group: European-headquartered regulatory, pharmacovigilance, and medical device consultancy. Overlaps directly with Clinpharma's PV/RA and medical-device vigilance offerings, with a similar multi-country delivery model.

Regional players

• PHARMAPACE: European clinical and pharmacovigilance CRO with strong footprint in Italy and German-speaking markets. Comparable boutique-style PV/RA delivery with regional overlap and similar sponsor targets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/clinpharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Clinpharma