Pitzek GMP Consulting

What Pitzek GMP Consulting does

Pitzek GMP Consulting GmbH is a privately held German professional services firm specializing in Good Manufacturing Practice (GMP) consulting for the pharmaceutical, biotech, medical device, food technology, and cosmetics industries. Founded approximately 2012 and headquartered in Neustadt an der Weinstraße with a Berlin branch, the firm employs 11–50 staff organized into specialized practice heads covering GMP Consulting/Project Management, Engineering, Qualification/Validation, Quality Management Systems (ISO 9001, ISO 13485), Technology Transfer, Computer System Validation (GAMP 5), and Hygiene/Contamination Control. Its customer base spans major pharmaceutical manufacturers (Boehringer Ingelheim, Roche, Bayer, AstraZeneca, Sanofi-Aventis, Merck KGaA), CDMOs (CordenPharma, Recipharm), biotech (Bavarian Nordic), and packaging/equipment suppliers, with services delivered on-site at client facilities across Germany.

The firm operates as a B2B professional services business with project-based engagements and multi-year contracts, supported by direct field sales, a Managing Director-led commercial team, and a Sales Manager. Marketing is primarily event-driven (LOUNGES cleanroom trade fair, PharmaCongress & PharmaTechnica) and content-driven (LinkedIn, XING, blog), with no public pricing and no self-serve or digital product channel. Revenue is not publicly disclosed; the firm maintains ISO 9001:2015 certification, repeat 'Arbeitgeber der Zukunft' recognition, and is expanding via strategic partnerships — notably with cellerata GmbH (ATMP/cell-and-gene therapy) and Integrated Device Solutions (medical devices and combination products).

Name

Pitzek GMP Consulting

Legal name

Pitzek GMP Consulting GmbH

Website

https://pitzek-consulting.de

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Pitzek GMP Consulting GmbH is a German professional services firm providing Good Manufacturing Practice (GMP) consulting, qualification, validation, QMS, and technology transfer services to pharmaceutical, biotech, medical device, and food manufacturers, delivered on-site across Germany via a two-office footprint.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ)

akta.pro secondary industries

GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL), GMP Manufacturing Support Services (QA/QMS, validation, documentation) (HLAAAKAH), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL)

Keywords

• GMP consulting
• Regulatory compliance
• Pharmaceutical compliance services
• Qualification validation
• Quality management consulting

Headquarters

HQ city

Neustadt An Der Weinstraße

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Professional Consulting Services: Project-based consulting engagements providing GMP advisory, project management, engineering, qualification/validation, QMS implementation, and technology transfer services to pharmaceutical, biotech, food, and medical device manufacturers.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels7 records

Core offering

Pitzek GMP Consulting provides specialized Good Manufacturing Practice (GMP) advisory, project management, engineering, qualification/validation, Quality Management System (QMS) implementation, technology transfer, computer system validation (CSV), and hygiene/contamination control services. Engagements are scoped, priced, and delivered as custom projects to pharmaceutical, biotech, medical device, food technology, and cosmetics manufacturers requiring EU GMP, FDA, PIC/S, and Annex 1 compliance in Germany.

Product overview

Pitzek GMP Consulting is a professional consulting services firm, not a software product company. The company offers a portfolio of interconnected GMP (Good Manufacturing Practice) consulting services for the pharmaceutical, biotech, and food industries. The core service offerings include GMP Consulting/Projektmanagement, GMP Engineering, GMP Qualifizierung/Validierung, Qualitäts-Managementsystem (QMS), Technologietransfer, Computersystemvalidierung (CSV)/Automatisierungstechnik, and Hygiene Services. These services work together to help clients achieve and maintain GMP/ISO 9001/ISO 13485 compliance and EU/FDA readiness throughout the entire product and facility lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• GMP Consulting / Project Management Core GMP advisory covering quality control, quality assurance, production, and technical service, with project management for efficient, disturbance-free facility operations in pharmaceutical, chemistry, and food-industry environments.
• GMP Engineering Engineering support across the full project lifecycle — conception, procurement, and implementation, including Basic and Detail Engineering, User Requirement Specifications (URS), complete specifications, supplier inquiries, and bid analysis.
• GMP Qualification / Validation Fully GMP-compliant qualification and validation projects for production of pharmaceuticals, APIs, cosmetics, food, and feed, including Master Plan creation, URS documentation, and DQ, IQ, OQ, PQ execution.
• Quality Management System (QMS) Services QMS design and implementation for EU and FDA readiness in pharmaceutical, medical device, and cosmetics industries, including concept, planning, audit preparation, document adaptation, and compliance support against GMP, ISO 13485, and ISO 9001.
• Technology Transfer Pharmaceutical technology transfer covering evaluation of original manufacturer information, raw materials, critical process parameters, equipment, and batch size per FDA scale-up guidelines, including development of transfer tools and thorough process validation.
• Computer System Validation (CSV) / Automation GAMP 5-compliant computer system validation with risk analysis, validation plans, engineering documentation, FAT/SAT testing, DQ/IQ/OQ/PQ execution, and data integrity concepts for MES, LIMS, ERP, eQMS, and SAP systems. Automation services include infrastructure concepts, electrical distribution planning, and 21 CFR Part 11 compliance.
• Hygiene and Contamination Control Services Hygiene concept development and implementation support, including cleaning and disinfection procedures per GMP Annex 1 requirements, gowning qualification, Contamination Control Strategy (CCS) development, environmental monitoring, pest control, and cleanroom clothing management.

Quantifiable outcome

• Helped clients pass regulatory audits and FDA inspections without findings through proactive compliance preparation
• +1 more outcomes

Named customers18 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• cellerata GmbHcoreStrategic or Co-development Partner · 1 April 2026Partnership to provide end-to-end ATMP (Advanced Therapy Medicinal Products) development and manufacturing support. cellerata contributes 15+ years of ATMP development, manufacturing, and digitalization/automation expertise; Pitzek provides 15 years of GMP compliance consulting. Joint offering covers 360° GMP project management, qualification, validation, QMS setup, and automation for ATMP products.
• GAT (GAT GmbH)coreGTM or Marketing Partner · 24 March 2026Joint exhibition at LOUNGES 2026 trade fair in Karlsruhe. Combined portfolio covers engineering, automation, assembly and commissioning, and qualification from a single source. Long-term partnership spanning multiple years of trade show presence.
• Integrated Device Solutions GmbH (IDS)coreStrategic or Co-development Partner · 1 February 2026Strategic partnership combining GMP excellence from Pitzek with Medical/Reinraum expertise from IDS. Focus on combination products, drug delivery devices, and Medical Devices (Class I-III). Joint offerings include systematic analysis, risk-based 360-degree view, and comprehensive GMP project management for ATMP and pharma/biotech segments.
• IAB Reinraum-Produkte GmbHminorGTM or Marketing PartnerCo-presentation partnership on cleanroom topics. Joint presentation with IAB and Dr. Weigert on 'Annex 1: Sicher durch den Dschungel der Anforderungen' at LOUNGES events.
• Chemische Fabrik Dr. WeigertminorGTM or Marketing PartnerJoint presentation partner on cleaning validation and contamination control topics. Co-presented at LOUNGES and Hecht PowerDays on Annex 1 compliance and cleaning validation.
• botecminorGTM or Marketing PartnerJoint exhibition partnership mentioned for LOUNGES 2024/2025 trade fair presence.
• BVMW (Bundesverband mittelständische Wirtschaft)minorOthersMember of BVMW, the German Mittelstand industry association, supporting the solidarity community of mid-sized enterprises.

Scale indicators4 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• PharmaLex (Cencora): Global regulatory affairs and pharmacovigilance consulting firm, now part of Cencora/Allergan Aesthetics — much larger scale and broader geographic reach, with overlapping GMP and regulatory service lines but a wider portfolio than Pitzek.
• Körber Pharma: German-headquartered pharma equipment, software, and consulting provider offering engineering, manufacturing IT, and regulatory services — broader scope than Pitzek, with overlap on qualification, validation, and pharma production projects.
• TÜV SÜD: Large German testing, inspection, certification, and training body offering GMP audits, ISO certification, and pharma compliance services — a broad incumbent competing for the same pharma QA/regulatory buyers, though within a much wider service portfolio.
• Bilfinger Engineering & Maintenance: European industrial services and engineering firm with a dedicated pharma and life sciences practice covering plant engineering, qualification, and GMP-related consulting — much larger scale and broader industry footprint, but directly comparable on pharma engineering and qualification engagements.

Direct peers

• Blue Inspection Body GmbH: German provider of GMP audits, supplier qualification, and quality compliance services to pharma and API manufacturers — overlaps Pitzek's audit preparation, CAPA, and supplier assessment capabilities.
• gempex GmbH: German GMP consulting and engineering firm offering qualification, validation, QMS, and GMP compliance services to pharmaceutical and life sciences manufacturers — a close niche competitor on the same service portfolio.
• VTU Engineering: Austrian/German engineering consultancy providing GMP process design, scale-up, and plant engineering for pharma and biotech — competes on engineering, technology transfer, and qualification projects with Pitzek.
• Pharmaplan (aginko group): German-headquartered engineering and consulting firm specializing in GMP-compliant facility design, qualification, and project execution for pharma and biotech — directly overlapping Pitzek's engineering, qualification, and project management service lines.
• Diapharm: German regulatory affairs and GMP consulting firm serving pharma, medical device, food, and cosmetics manufacturers — competing on regulatory, quality, and product compliance mandates similar to Pitzek's QMS and technology transfer offerings.
• Concept Heidelberg: Heidelberg-based organizer of GMP conferences, training, and consulting services for the pharmaceutical industry — comparable in customer overlap (pharma QA/RA/validation professionals) though more weighted toward events and training than on-site project delivery.

Market position

Strengths5 records

Weaknesses2 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xxing.com/pages/pitzekgmpconsultinggmbh
• LinkedInlinkedin.com/company/pitzek-consulting

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Pitzek GMP Consulting