Qualipharma

What Qualipharma does

Qualipharma is a privately-held Spanish pharmaceutical and life sciences consulting firm headquartered in Alcobendas, Madrid, founded in 2001. The company delivers professional services across four core consulting units — Pharmaceutical Quality System & Compliance (PQS), Commissioning Qualification Validation (CQV), Computer System Validation (CSV) and Computer Software Assurance (CSA), and Regulatory Affairs — covering the full product lifecycle for clients governed by international GxP, FDA, and ISO 13485 standards. It serves at least nine regulated verticals, including human and veterinary pharmaceuticals, biotechnology, advanced therapy medicinal products (ATMPs), medicinal cannabis, medical devices, dietary supplements, cosmetics, hospital pharmacy, and biosafety, with reported activity of 999+ annual projects delivered to clients in multiple countries from a single Spanish headquarters.

The firm's underlying technology base extends beyond pure advisory work. Qualipharma has productized four distinct digital solutions: Qloud (cloud-based compliance platform), e-Learning (training platform for pharmaceutical professionals), Match Consulting (consultant-matching platform), and Dossierfy (regulatory dossier and variation management platform for eCTD-format documentation). These digital assets layer software-style functionality on top of the consulting practice and represent the firm's most credible pathway to recurring, non-billable-hour revenue.

The business model is sales-led, project-based professional services sold through direct B2B engagement via the company's website, contact forms, and a publicly listed email/phone channel. Pricing is not publicly disclosed and is reached through direct consultation, consistent with bespoke GxP engagements. Revenue is generated almost entirely through fee-for-service consulting engagements, with the digital solutions functioning as supplementary channels. The firm is privately held with no disclosed institutional investors, funding rounds, acquisitions, or parent-company relationships, suggesting it has scaled organically over 24 years to a headcount of 101–250 employees. Marketing is concentrated in content (a multilingual blog, LinkedIn, YouTube, and newsletter) and serves primarily as top-of-funnel demand generation for consulting engagements.

Name

Qualipharma

Legal name

Qualipharma

Website

https://qualipharmagroup.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

101–250 employees

Short description

Qualipharma is a Madrid-based pharmaceutical consulting firm (founded 2001, 101–250 employees) that delivers GxP, FDA, and ISO 13485 compliance, validation, and regulatory affairs services to nine regulated life sciences verticals, supplemented by four productized digital solutions including Dossierfy.

Ownership category

akta.pro rank

Product category

Pharmaceutical Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Professional, Scientific, and Technical Services (541), Computer Systems Design and Related Services (54151)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG), Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE)

Keywords

• Pharmaceutical consulting
• Quality systems compliance
• CSV CSA validation
• Regulatory affairs services
• CQV commissioning qualification

Headquarters

HQ city

Alcobendas

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Pharmaceutical Consulting Services: Professional consulting services for pharmaceutical quality systems, regulatory compliance, computer system validation, commissioning and qualification, and regulatory affairs. Revenue generated through project-based consulting engagements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Qualipharma provides specialized consulting services in Quality Systems, Commissioning Qualification Validation (CQV), Computer System Validation/Assurance (CSV/CSA), and Regulatory Affairs to pharmaceutical, biotech, medical device, advanced therapy, cannabis, dietary supplement, cosmetic, hospital, and biosafety organizations. Complementing its consulting practice, the company offers digital solutions — Qloud, e-Learning, Match Consulting, and Dossierfy — to support compliance, training, consultant sourcing, and dossier management workflows.

Product overview

Qualipharma is a global pharmaceutical consulting firm offering a portfolio of four core consulting service units and four digital solutions. The core business units include: Pharmaceutical Quality System & Compliance (PQS) providing comprehensive consulting across the product lifecycle; Commissioning Qualification Validation (CQV) for equipment and facility qualification; Computer System Validation (CSV) & Assurance (CSA) for digitization projects and data integrity; and Regulatory Affairs for compliance in product commercialization. The digital solutions portfolio includes Qloud (cloud-based platform), e-Learning (training platform), Match Consulting (consultant matching), and Dossierfy (regulatory dossier management tool). The company operates under international GxP, FDA, and ISO 13485 quality standards.

Differentiator

Problem solved

Functional benefit

Brands

• Qloud by Qualipharma: Digital solution platform offered by Qualipharma
• e-Learning by Qualipharma
• Match Consulting by Qualipharma
• Dossierfy

Products and services

• Quality Systems Consulting Advisory and implementation services for GxP-aligned quality management systems for pharmaceutical, biotech, medical device, advanced therapy, cannabis, dietary supplement, cosmetic, hospital, and biosafety organizations.
• CQV (Commissioning, Qualification, Validation) Consulting Commissioning, qualification, and validation services for facilities, equipment, and processes at life sciences manufacturers and laboratories.
• CSV/CSA (Computer System Validation / Computer Software Assurance) Consulting Validation and assurance services for computerized systems used in regulated life sciences environments, supporting GxP compliance.
• Regulatory Affairs Consulting Regulatory strategy, dossier preparation, and submission support for life sciences companies across multiple jurisdictions and product types.
• Qloud Digital quality/compliance platform supporting pharmaceutical and life sciences clients in managing quality system processes.
• e-Learning Online training modules delivering GxP, quality, validation, and regulatory content to life sciences professionals.
• Match Consulting Digital platform for matching life sciences clients with qualified consulting specialists for project engagements.
• Dossierfy Digital platform for regulatory dossier preparation, management, and submission tracking.

Segments9 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• ICON plc: ICON is a global CRO with regulatory and quality consulting capabilities serving pharma and biotech, representing a larger-scale incumbent competing for the same regulated-industry consulting wallet as Qualipharma.
• Veeva Systems: Veeva is a large incumbent cloud-software provider for life sciences with regulatory, quality, and validation products that overlap with Qualipharma's Dossierfy and CSV service lines, though Veeva sells standardized SaaS rather than bespoke consulting.
• IQVIA: IQVIA is a global CRO and life-sciences technology firm offering regulatory, quality, and compliance consulting at scale, competing with Qualipharma on enterprise regulatory affairs and quality engagements.

Direct peers

• PharmEng Technology: PharmEng Technology delivers commissioning, qualification, validation, and regulatory compliance services to pharmaceutical manufacturers — closely matching Qualipharma's CQV and CSV service portfolio.
• Voisin Consulting Life Sciences: Voisin Consulting Life Sciences is a regulatory affairs and quality compliance consultancy serving pharma, biotech, and medical-device clients, directly comparable to Qualipharma's Regulatory Affairs and PQS units.
• Kymanox: Kymanox provides life-sciences engineering, validation, regulatory, and quality services, with strong overlap to Qualipharma's CQV and Quality Systems offerings, particularly in biotech and advanced therapies.
• ProPharma Group: ProPharma Group is a global pharmaceutical compliance, regulatory affairs, and quality consulting firm with overlapping GxP, validation, and regulatory services serving pharma, biotech, and medical-device manufacturers — directly competing with Qualipharma across most of its core service units.
• Verista (formerly Maetrics): Verista provides GxP compliance, Computer System Validation, and quality consulting to life-sciences companies, directly overlapping with Qualipharma's CSV and Quality Systems service lines.
• NNIT (now part of Novo Nordisk): NNIT provides IT services to the life-sciences industry including CSV, GxP IT compliance, and digital transformation consulting, overlapping directly with Qualipharma's CSV/CSA and Data Integrity practices.
• PharmaLex (now part of Veristat): PharmaLex is a global provider of regulatory affairs, quality compliance, and pharmacovigilance services to pharma and biotech — directly comparable to Qualipharma's Regulatory Affairs and pharmacovigilance offerings.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@qualipharmaconsultoriagmpy2467
• LinkedInlinkedin.com/company/qualipharma

Compliance3 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 Qualipharma