Granzer Regulatory Consulting & Services

What Granzer Regulatory Consulting & Services does

Granzer Regulatory Consulting & Services GmbH is a Munich-based, founder-owned regulatory consulting firm founded in 2002 by Dr. Ulrich Granzer. The company provides expert regulatory support for global drug and medical device development, serving more than 1,000 cumulative clients across large pharmaceutical companies, biotechnology firms, medical device manufacturers, and SME drug developers in Europe, North America, Japan, Australia, and Asia. The firm positions itself as a one-stop shop spanning the full drug development value chain — from early nonclinical strategy through marketing authorisation and post-approval lifecycle management — and handles nearly 1,000 regulatory submissions annually, alongside multiple Scientific Advice meetings, Orphan Drug designations, and Paediatric Investigational Plans each year.

The operating model is structured around six core expert teams: CMC/Devices, Nonclinical, Clinical/Regulatory, Medical Writing, Regulatory Project Management, and E-Submission/Regulatory Operations. These teams are supported by specialised service modules covering regulatory strategy, orphan drug development, paediatric plans, medical devices and combination products, due diligence, GMP compliance, and market access. The consultant base of 60+ professionals includes European Registered Toxicologists and individuals with prior tenure at regulatory authorities, large pharma, and biotech, and the firm cites involvement in industry firsts including the first peptide-based vaccines, gene therapy, mRNA developments, CAR-Ts, CRISPR/Cas, and Covid vaccine marketing authorisation.

Commercially, Granzer operates a direct, expert-led professional services model delivered through senior consultants rather than digital or self-serve channels. Pricing is not publicly disclosed and is structured as project-based or retainer engagements. The firm has no external institutional investors, no subsidiaries, and no public funding history, and is governed by a managing-director team led by Dr. Ulrich Granzer (CEO), Jens Schletter (COO), and Stefan Blesse (CSO). A complementary collaboration with the related entity Granzer Pharmaceutical Services extends the offering into GMP audits, investigational product storage, and Qualified Person services, enabling cross-referral within an extended Granzer service network.

Name

Granzer Regulatory Consulting & Services

Legal name

Granzer Regulatory Consulting & Services GmbH

Website

https://granzer.biz

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

51–100 employees

Short description

Granzer Regulatory Consulting & Services is a Munich-based, founder-owned firm providing expert regulatory consulting for global drug and medical device development, serving over 1,000 clients across pharma, biotech, device, and SME segments since 2002.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC) (HLAGAKAB), Nonclinical Study Management & Regulatory Writing (IND-enabling) (HLAGAFAN)

Keywords

• Regulatory affairs consulting
• Drug development consulting
• Medical device consulting
• Pharmaceutical regulatory services
• Clinical regulatory strategy

Headquarters

HQ city

Muenchen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Regulatory Consulting Services: Professional consulting services for drug and device development spanning from early nonclinical development through licensure. Services are tailored to client needs and likely delivered on a project or retainer basis.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels2 records

Core offering

Granzer provides end-to-end regulatory consulting for global drug and medical device development, supporting pharmaceutical, biotech, and medical device companies from early nonclinical development through licensure. Services span CMC/Devices, Nonclinical, Clinical/Regulatory, Medical Writing, Regulatory Project Management, and E-Submission/eCTD publishing, delivered as a one-stop-shop across Europe, North America, Japan, Australia, and Asia.

Product overview

Granzer Regulatory Consulting & Services is a regulatory consulting firm offering a comprehensive, integrated suite of services for global drug and device development. The company provides expert guidance across the entire value-generating chain of drug development from early nonclinical development to licensure. Their portfolio consists of six core expert teams—CMC/Devices, Nonclinical, Clinical/Regulatory, Medical Writing, Regulatory Project Management, and E-Submission/Regulatory Operations—supported by specialized service modules covering regulatory strategy, orphan drug development, paediatric development, medical devices, due diligence, GMP compliance, and market access. The integrated approach combines these services to optimize time to market for pharmaceutical, biotech, and device companies.

Differentiator

Problem solved

Functional benefit

Products and services

• CMC / Devices Regulatory Services Comprehensive regulatory CMC (Chemistry, Manufacturing, and Controls) support throughout the drug development process, integrated with regulatory strategy, project management, devices, and eCTD publishing.
• Nonclinical Regulatory Services Nonclinical development support including study design, regulatory interaction strategies, IND/CTA filings, and nonclinical CTD module preparation for all drug development stages.
• Clinical / Regulatory Services Clinical development program definition and regulatory strategy support tailored to meet expectations of regulatory agencies, payors, and the medical community.
• Medical Writing Services Preparation of regulatory documents including clinical study protocols and reports, investigator brochures, marketing applications, non-clinical and clinical summaries, clinical overviews, risk management plans, and product information documents.
• Regulatory Project Management Integrated project development planning, multidisciplinary team management, regulatory agency interactions coordination (Scientific Advice, PIP, ODD), and marketing application coordination.
• E-Submission / Regulatory Operations Publishing services including eCTD dossier compilation, document formatting, submission via electronic gateways, validation, and lifecycle management for EU, US, UK, Switzerland, Canada, and other regions.
• Regulatory Strategy Services Comprehensive regulatory strategy development throughout all phases of drug and device development, including early development strategy, orphan drug development, paediatric development, and due diligence assessments.
• Orphan Drug Development Services Regulatory support for orphan drug designation requests filed successfully globally.
• Paediatric Development Services Preparation and management of Paediatric Investigational Plans globally.
• Medical Devices and Combination Products Services Regulatory support for medical devices and combination products, including borderline products.
• Due Diligence Services Regulatory due diligence assessments for drug development programs.
• GMP Compliance & Storage Services GMP compliance support and storage services for investigational products.
• Market Access Services Support for Health Technology Assessments and payor organization integration.
• Regulatory Procedures Services Procedural management of filing and approval processes for marketing authorization applications.
• Early Development Strategy Services Strategy development, creation of development plans, and prioritization support for early-stage drug development.

Quantifiable outcome

• Successfully supported over 1,000 clients globally
• +2 more outcomes

Named customers4 records

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.

• Granzer Pharmaceutical ServicescoreOthersGranzer Regulatory Consulting & Services collaborates with Granzer Pharmaceutical Services for GMP audits, import/storage of investigational products, and QP (Qualified Person) services. This appears to be a related entity under the same organizational umbrella, providing complementary pharmaceutical services.

Scale indicators7 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• NDA Group: NDA Group is a regulatory and HTA advisory firm serving pharma and biotech across EU, US and Japan. Highly comparable to Granzer's integrated regulatory strategy, CMC, nonclinical and clinical regulatory offerings and similar SME-to-large-pharma client mix.
• ProPharma Group: ProPharma Group provides regulatory affairs, compliance, pharmacovigilance and quality consulting to pharma and biotech. Overlaps directly with Granzer's regulatory strategy, CMC, nonclinical and submission services for life sciences sponsors.
• PharmaLex (Cencora): PharmaLex is one of the largest pure-play regulatory and compliance consulting services for pharma and biotech, now part of Cencora. Directly comparable to Granzer in scope: regulatory strategy, CMC, nonclinical, clinical regulatory, medical writing, e-submissions and global submissions across EU, US and Asia.
• Voisin Consulting Life Sciences (VCLS): VCLS is a Europe-based regulatory and scientific consulting firm supporting drug development from nonclinical through market authorization. Closely comparable to Granzer: global regulatory strategy, CMC, clinical-regulatory, medical writing and health authority interactions for pharma and biotech sponsors.

Broad incumbents

• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-to-large CRO with regulatory and scientific affairs services supporting global drug development. Comparable to Granzer in regulatory strategy and submissions but bundled within a larger clinical CRO offering.
• ICON plc: ICON is a global CRO with dedicated regulatory affairs, biopharma services and consulting capabilities. Competes with Granzer on global regulatory strategy and submissions as part of a much wider clinical and laboratory service portfolio.
• Premier Research: Premier Research is a clinical and regulatory CRO with strong focus on small/mid-biotech and rare disease programs. Comparable to Granzer's SME biotech focus and regulatory consulting, but bundled with full clinical trial execution services.
• IQVIA: IQVIA is the world's largest CRO and healthcare data company, offering regulatory affairs, R&D consulting and submissions globally. Competes with Granzer on regulatory strategy and submission execution but with significantly greater scale, technology assets and geographic reach.
• Charles River Laboratories: Charles River is a global CRO/CDMO offering regulatory, discovery, safety assessment and manufacturing services. Its regulatory and safety consulting arm overlaps with Granzer's nonclinical and CMC regulatory practices, but as a larger, broader player.
• Parexel International: Parexel is a global full-service CRO that bundles regulatory affairs, clinical, biostatistics and consulting across all major regions. Competes with Granzer on regulatory consulting and submissions but at much greater scale and with broader service breadth.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/granzer-regulatory-consulting

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 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 Granzer Regulatory Consulting & Services