What Qualitech Engineering & Compliance does

Qualitech Engineering & Compliance is a privately held Greek boutique consultancy, headquartered in Nea Ionia (Athens), that delivers engineering and validation services to regulated industries — primarily pharmaceutical manufacturers, with adjacent coverage of life sciences, cosmetics, medical devices, food, hospitals, and nutraceutical/cannabis operators. Its service portfolio spans engineering and construction supervision, equipment and HVAC qualification, clean room validation, cleaning and life cycle validation, computerized systems validation (CSV), GxP auditing, ongoing compliance consultancy, and COVID-era disinfection and indoor air quality work. The firm positions itself as the first Greek provider combining Equipment Qualification, Quality Assurance, Pharmaceutical Engineering, and Software/CSV under a single roof, and claims more than 100 protocols executed across clean rooms, HVAC, and machine qualification for pharma clients.

The business operates a B2B sales-led model: project-based consulting fees are quote-based and not publicly disclosed, while a recently added paid training line (EU GMP seminars on Annex 11 and AI Revisions) sells at €350–€450 per attendee with early-bird and group tiers. Go-to-market combines direct enterprise engagement with a network of 15 technology and validation partners (including Arvato Systems, dotcompliance, Conval Group, Telstar, and Labware), supported by blog content, webinars, and industry seminars. Geographic reach covers Greece and selected European projects in Italy and North Macedonia, including a milestone first GMP audit certification for a North Macedonian herbal medicine plant in 2023. Revenue is undisclosed, the team is six employees, and there is no evidence of external investment, positioning the company as an independently owned specialist micro-firm.

Name

Qualitech Engineering & Compliance

Legal name

QUALITECH ENGINEERING & COMPLIANCE

Website

https://qualitechengineering.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Qualitech Engineering & Compliance is a privately held Greek consultancy providing GxP-compliant engineering, qualification, validation, and auditing services to pharmaceutical, life sciences, cosmetics, medical device, food, and hospital clients across Greece and select European markets.

Ownership category

akta.pro rank

Product category

Pharmaceutical Engineering & Validation Services

NAICS

Testing Laboratories and Services (54138), Engineering Services (541330)

SIC

Services-Testing Laboratories (8734), Services-Engineering Services (8711)

akta.pro primary industry

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

akta.pro secondary industries

GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE), Computer System Validation (CSV) & GxP IT Compliance (21 CFR Part 11/Annex 11) (HLAGAKAG), Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL), Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE), Supplier Quality Assurance & Vendor Approval Programs (AFALALAB)

Keywords

• Pharmaceutical validation services
• GxP compliance consulting
• Clean room engineering
• Computerized systems validation
• Regulated industry auditing

Headquarters

HQ city

Nea Ionia

HQ country

Greece

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. Consulting Services: Professional engineering and validation consulting services for pharmaceutical and life sciences companies, including qualification, validation, GxP auditing, and compliance consultancy.
2. Training Seminars: Educational seminars on regulatory topics such as EU GMP Chapter 4, Annex 11, and AI governance. Fees range from €350-450 per attendee depending on registration timing and group bookings.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Qualitech Engineering & Compliance provides engineering, qualification, and validation services for GxP-regulated industries, including pharmaceutical, life sciences, cosmetics, medical device, and food companies. Its work spans engineering and construction project management, qualification and validation of equipment and processes, ongoing compliance consultancy, computerized systems validation, GxP auditing, clean room and HVAC engineering, food quality systems, and R&D for nutraceuticals. The firm also runs a training and educational seminar program that serves as a secondary revenue stream.

Product overview

Qualitech Engineering & Compliance is a Greek consulting firm offering engineering and validation solutions for the pharmaceutical and life sciences sectors. The company provides a comprehensive portfolio of services including qualification and validation activities, computerized systems validation, GxP auditing, clean room engineering, food quality systems, and specialized COVID-19 disinfection services. The company operates with a team experienced in both engineering and regulatory affairs, serving Greek and international companies with expertise in FDA, MHRA, EU GMP, and other international regulatory standards. Services are delivered through project-based consulting engagements focused on compliance achievement, quality assurance, and regulatory adherence rather than software products.

Differentiator

Problem solved

Functional benefit

Products and services

• Engineering and Construction Project Management Comprehensive engineering and construction project management services for regulated industry facilities, covering design, build, and commissioning oversight for clients in pharmaceutical, life sciences, cosmetics, medical device, and food sectors.
• Qualification and Validation Services (Q&V) Qualification and validation of equipment, processes, utilities, and facilities to GxP and ISO standards for regulated manufacturers.
• Ongoing Compliance Consultancy Continuous compliance support for regulated clients, helping maintain audit-ready operations and respond to regulatory requirements.
• Computerized Systems Validation (CSV) Validation of computerized systems used in regulated environments, including software development and validation, for pharmaceutical, life sciences, medical device, and related clients.
• GxP Auditing Good Practice (GxP) auditing services to support compliance with pharmaceutical, life sciences, cosmetics, and medical device regulatory standards.
• Clean Room and HVAC Engineering & Validation Engineering, validation, and maintenance of clean rooms and HVAC systems for controlled environments, including indoor air quality validation.
• Food Quality System Implementation Design and implementation of food quality and safety systems (ISO/HACCP-aligned) for food production clients.
• R&D Projects for Nutraceuticals Research and development support for nutraceutical products, delivered to clients in the food and life sciences sectors.
• Cleaning Validation and Modern Cleaning Investigation Cleaning validation and modern cleaning investigation services to verify and optimize cleaning processes in regulated manufacturing environments.
• COVID-19 Disinfection Control Disinfection control validation and support services developed in response to COVID-19 for facilities requiring controlled bioburden management.
• Educational and Training Seminars Paid training seminars covering GxP, risk management, food safety, cleaning validation, HVAC, and microbial levels for quality and compliance professionals in regulated industries.

Quantifiable outcome

• First North Macedonian site to receive GMP Audit Certification
• +2 more outcomes

Named customers6 records

Segments7 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• arvato-systemscoreTechnology or IntegrationStrategic partner for serialization and track & trace technology. Joint webinar hosted on consumer products track & trace technology. Major technology partner.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Regional players

• Particle Measuring Systems: Particle Measuring Systems provides contamination monitoring and clean room certification instruments and services. Adjacent peer to Qualitech's clean room validation and indoor air quality work, with focus on particle counters and microbial monitoring.
• Telstar: Telstar (a Carbotica Group company) provides life sciences engineering, clean room, lyophilization, and sterilization solutions globally. Overlap with Qualitech in clean room engineering and pharmaceutical facility qualification, though Telstar focuses more on equipment supply.

Others

• LabWare: LabWare is a leading LIMS (Laboratory Information Management System) provider for pharma and life sciences. Complementary partner to Qualitech's CSV services, enabling computerized system validation work for LIMS implementations.

Direct peers

• Conval Group: Conval Group provides validation and qualification services for pharmaceutical, biotech, and medical device industries across Europe. Direct competitor offering the same GxP validation, CSV, and clean room qualification services as Qualitech.
• QbD Group: QbD Group is a Belgian-headquartered consultancy specializing in pharmaceutical quality, validation, and regulatory compliance services. Comparable to Qualitech in core GxP and validation offerings, but operating at significantly larger scale across Europe.
• KVALITO: KVALITO is a Swiss-based life sciences consultancy offering CSV, validation, and quality management services to pharma and biotech clients. Highly comparable to Qualitech's CSV and qualification portfolio, with similar team-based delivery model.

Broad incumbents

• PharmaLex: PharmaLex (now part of Cencora) is a major pharma regulatory, compliance, and quality consulting provider. Comparable to Qualitech's regulatory and GMP compliance services, but with a global footprint and broader service portfolio.
• Vaisala: Vaisala provides industrial measurement solutions including clean room monitoring, humidity, and CO2 sensors. Comparable to Qualitech's indoor air quality and HVAC validation services, though Vaisala is primarily a hardware/instrument vendor rather than a consultancy.
• ProPharma Group: ProPharma Group is a well-established global pharma compliance, regulatory, and quality consulting firm. Larger incumbent offering overlapping GxP auditing, validation, and quality assurance services across multiple regulated verticals.

Emerging players

• dotcompliance: dotcompliance offers a SaaS-based quality management and compliance platform for pharma and life sciences. Complementary to Qualitech's consulting services, with potential overlap in computerized systems validation and QMS implementation.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/qualitechengineering

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 Qualitech Engineering & Compliance