GALEAPHARMA ASESORES FARMACEUTICOS SL

What GALEAPHARMA ASESORES FARMACEUTICOS SL does

GALEAPHARMA ASESORES FARMACEUTICOS SL is a privately held, boutique pharmaceutical consultancy headquartered in Pozuelo de Alarcón, Madrid, Spain. The firm delivers integrated regulatory affairs, pharmacovigilance, GxP auditing, and training services to companies operating across human medicines, veterinary medicines, cosmetics, food supplements, medical devices, and medicinal plants. Services span the full product lifecycle — from registration dossier preparation and clinical trial support through marketing authorization maintenance, post-market surveillance, and quality system development — and are priced on a project/quote basis rather than as recurring subscription contracts. The firm operates a horizontal segmentation approach, serving clients of varying size within each regulated vertical, and engages via a direct, consultative sales motion with senior consultants acting as a single point of contact for each account.

The underlying operating model is built around a small, senior team of five named consultants. Founder and Director General Javier Galdona brings 35+ years of pharmaceutical industry experience; Senior Consultant Beatriz Fernández adds 15+ years with prior tenures at Roche and Wyeth Pharma; the remaining consultants cover cosmetics/medical devices/food supplements, registries/pharmacovigilance, and pharmacovigilance/registries respectively. Several team members hold UK or broader EU experience and advanced degrees (CESIF, ESAME). The firm presents itself as operating as an extension of the client's regulatory department, with personalized service delivery rather than standardized process outsourcing.

The go-to-market is sales-led and relationship-based, supported by a company website and LinkedIn presence, plus a strategic partnership with the RegulaNet consortium for cross-jurisdictional regulatory referrals. Geographic reach is primarily Spain, with documented service delivery into Belgium, France, and Portugal. Revenue is generated entirely through professional services engagements, with no disclosed SaaS, software, or productized offering; financial scale is undisclosed, and the firm operates without external venture capital, private equity, or parent-company backing.

Name

GALEAPHARMA ASESORES FARMACEUTICOS SL

Legal name

GALEAPHARMA ASESORES FARMACÉUTICOS, S.L.

Website

https://galeapharma.es

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

GALEAPHARMA is a privately held, boutique pharmaceutical consultancy in Madrid, Spain, providing regulatory affairs, pharmacovigilance, GxP auditing, and training services to human pharma, veterinary, cosmetics, food supplement, medical device, and medicinal plant companies in Spain and select European markets.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Professional, Scientific, and Technical Services (541)

SIC

Services-Misc Health & Allied Services, Nec (8090), Services-Management Consulting Services (8742)

akta.pro primary industry

Medical Review & Pharmacovigilance Quality (PV QA/Audits/SOPs) (HLAGALAH)

akta.pro secondary industries

PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited) (HLAGALAJ), Patient Support Programs & Device/Vaccine Vigilance (PSP/PSUR support) (HLAGALAK), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Pharmaceutical regulatory consulting
• Pharmacovigilance services
• GxP auditing compliance
• Medical device registration
• Cosmetics regulatory affairs

Headquarters

HQ city

Madrid

HQ country

Spain

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: Professional consulting services for regulatory affairs including dossier preparation, submission tracking, and maintenance of marketing authorizations for pharmaceutical companies, cosmetics manufacturers, and health product companies.
2. GxP Auditing Services: Auditing services for GxP compliance including GMP/GDP audits, supplier audits, and preparation for regulatory inspections.
3. Training Services: On-site and remote training courses in pharmacovigilance, Good Distribution Practices, and Good Manufacturing Practices.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels2 records

Core offering

Galeapharma is a boutique pharmaceutical consultancy providing integrated regulatory affairs, pharmacovigilance, GxP auditing, and training services to health-sector companies. It serves manufacturers and marketers of human medicines, veterinary medicines, cosmetics, food supplements, medical devices, and medicinal plants across Spain and selected European markets, acting as the single point of contact and managing client projects as an extension of the client's own team.

Product overview

Galeapharma is a boutique pharmaceutical advisory firm offering integrated consulting services to health sector companies. The company operates as a unified service offering rather than a software platform, providing specialized consulting across regulatory affairs, pharmacovigilance, GxP compliance, and auditing services. Their portfolio covers multiple therapeutic areas including human medicines, veterinary medicines, cosmetics, food supplements, medical devices, and medicinal plants. Services are delivered through personalized, client-dedicated teams with expertise spanning all phases of the product lifecycle from development through distribution.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs (Asuntos regulatorios) Comprehensive regulatory affairs support for health-sector companies, including preparation of registration dossiers, administrative procedures before health authorities, pricing and reimbursement applications, and expert reports. Designed for pharmaceutical, veterinary, cosmetics, food supplement, medical device, and medicinal plant manufacturers.
• Pharmacovigilance (Farmacovigilancia) Collection, evaluation, notification, and follow-up of adverse drug reactions in accordance with Good Vigilance Practices (GVP). Aimed at pharmaceutical and veterinary manufacturers needing ongoing pharmacovigilance operations.
• GxP (Good Practices) Services Comprehensive GxP services including auditing of manufacturing plants, transport, and storage; training courses; quality system development; and regulatory compliance support. Targeted at pharmaceutical manufacturers and distributors needing GMP/GDP compliance.
• Human Medicines (Medicamentos de uso humano) Regulatory support for human medicines throughout the product lifecycle from clinical trials through revocation, including marketing authorization maintenance, reimbursement, clinical trials, and business development services. Targeted at human pharmaceutical companies.
• Veterinary Medicines (Medicamentos de uso veterinario) Regulatory support for veterinary medicines including registration dossier preparation, marketing authorization applications, pharmacovigilance, and facility design. Targeted at veterinary pharmaceutical manufacturers and marketers.
• Medical Devices (Productos sanitarios) Support for medical device companies including distributor/importer registration, licensing, commercialization notifications, advertising authorization, and market surveillance. Targeted at medical device manufacturers and distributors operating in the EU under Regulation 2017/745.
• Cosmetics (Cosméticos) Cosmetics regulatory services including Product Information File (PIF) preparation, safety reports per EU Regulation 1223/2009, labeling review, manufacturer authorization, and cosmetovigilance. Targeted at cosmetics manufacturers and marketers.
• Food Supplements (Complementos alimenticios) Food supplement support including RGSEAA registration, market notification in Spain and EU countries, labeling review, galenic development, and stability studies. Targeted at food supplement developers and marketers.
• Medicinal Plants (Plantas medicinales) Regulatory support for medicinal plants including registration dossiers, administrative procedures, market surveillance, and compliance with applicable regulations. Targeted at companies in the medicinal plants and traditional medicine sector.
• Auditing Services (Auditorías) Audit services for healthcare-sector companies with national and international experience, including preparation for regulatory inspections and third-party supplier audits. Targeted at pharmaceutical, veterinary, cosmetics, food supplement, and medical device companies.
• Training Services On-site and remote training courses in pharmacovigilance, Good Distribution Practices, and Good Manufacturing Practices. Targeted at staff of pharmaceutical and health product companies needing qualification.

Named customers2 records

Segments6 records

Ideal customer profiles2 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.

• RegulaNetcoreGTM or Marketing PartnerStrategic partnership with RegulaNet consortium, a specialized consortium in Regulatory Affairs. This partnership enhances Galeapharma's regulatory affairs capabilities and market reach, particularly for clients requiring specialized regulatory support across different jurisdictions.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• IQVIA: Global CRO and life sciences services leader with a regulatory affairs and safety division covering pharmacovigilance, GxP, and regulatory submissions. Represents the largest competitive threat through scale, technology, and global coverage.
• PharmaLex (now part of Cencora): Large European pharma regulatory and PV consulting firm offering a comparable spectrum of regulatory affairs, pharmacovigilance, and quality compliance services. Operates at significantly greater scale across many more jurisdictions than Galeapharma.
• Pivotal: European CRO offering regulatory affairs, clinical trial, and pharmacovigilance services. Comparable service lines but larger scale and broader geographic reach than Galeapharma.
• Parexel: Major global CRO with regulatory consulting, pharmacovigilance, and GxP services. Competes for enterprise pharma clients with end-to-end service delivery that smaller boutiques like Galeapharma cannot match.
• Charles River Laboratories: Global CRO with established regulatory and pharmacovigilance consulting offerings. Represents the largest end of the competitive spectrum against which boutique consultancies like Galeapharma must differentiate.
• ICON plc: Global CRO with regulatory and pharmacovigilance service capabilities. Competes for the same enterprise pharma clients but at materially greater scale and with broader technology-enabled offerings.

Direct peers

• Asphalion: Barcelona-based pharma regulatory and scientific consultancy offering regulatory affairs, pharmacovigilance, and GxP services across EU markets. Closest comparable to Galeapharma in geography, size, and service mix, with a similar boutique positioning and Spanish-base.
• Voisin Consulting Life Sciences: French-based life sciences regulatory consulting firm with strong pharmacovigilance and regulatory affairs offerings. Comparable boutique-to-mid-market positioning with EU-wide delivery and similar vertical expertise.
• Regulis: European pharma regulatory and quality consulting firm offering regulatory affairs, pharmacovigilance, and GxP services. Direct competitor in the mid-market regulatory consulting space across Europe.

Regional players

• InJena Consultores: Spanish pharma consulting firm offering regulatory affairs, PV, and quality services. Operates in the same Spanish market as Galeapharma with overlapping service offerings and customer types.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/galeapharma-asesores-farmaceuticos-sl

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 GALEAPHARMA ASESORES FARMACEUTICOS SL