Klassen Consulting

What Klassen Consulting does

Klassen Consulting is a single-member regulatory affairs consulting firm led by principal Dan Klassen, serving pharmaceutical, biotechnology, and biological drug product companies in the United States and internationally. The firm is headquartered in Livingston, NJ (registered as an LLC in Texas) and operates with 1-10 employees, functioning essentially as a principal-led boutique practice. Its core offering is highly specialized consulting on U.S. FDA Chemistry, Manufacturing, and Controls (CMC) submissions (IND, NDA, BLA, DMF), cGMP compliance auditing, regulatory action remediation (483s, warning letters, consent decrees), quality systems development, and training. The firm also acts as U.S. Agent for foreign manufacturers requiring U.S. regulatory representation.

Name

Klassen Consulting

Legal name

Klassen Consulting, LLC

Website

https://klassenconsulting.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Klassen Consulting is a sole-practitioner regulatory affairs firm led by Dan Klassen, providing FDA CMC submission guidance, cGMP compliance auditing, and regulatory action remediation to pharmaceutical, biotech, and biological drug product companies.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

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

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC) (HLAGAKAB)

akta.pro secondary industries

Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF), Training & Competency Programs for GxP Compliance (HLAGAKAM)

Keywords

• Pharmaceutical regulatory consulting
• CMC regulatory affairs
• CGMP compliance auditing
• FDA action remediation
• Biotech regulatory services

Headquarters

HQ city

Livingston

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Regulatory Consulting Services: Professional consulting engagements providing regulatory affairs guidance, CMC documentation services, cGMP compliance auditing, and regulatory action remediation. Services are likely billed on project or hourly basis given the nature of specialized regulatory consulting engagements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Klassen Consulting, LLC provides expert regulatory affairs and compliance consulting services for pharmaceutical, biotechnological, and biological sterile injectable drug product companies. Its core offerings cover CMC regulatory consultation for IND, NDA, BLA, and DMF submissions, cGMP compliance auditing for suppliers and manufacturers, regulatory action remediation (483s, warning letters, consent decrees), quality systems development, project and crisis management, professional training on FDA inspections and GMP regulations, and US Agent representation for foreign manufacturers. All services are delivered directly by principal Dan Klassen on a project or hourly basis.

Product overview

Klassen Consulting is a professional services firm offering regulatory affairs and compliance consulting for the pharmaceutical, biotechnological, and biological drug products industry. The firm operates as a single integrated consulting practice rather than a platform-based product architecture. The core offerings include CMC Regulatory Consultation (covering IND, NDA, BLA, and DMF submissions), Regulatory Compliance Services (including GMP audits and remediation), Quality Assurance and Quality Systems development, Project and Crisis Management for regulatory action situations, Training Services on FDA inspections and GMP regulations, and US Agent Services for foreign manufacturers. All services are delivered through Dan Klassen's direct consulting expertise, supplemented by client testimonials and experience across therapeutic areas including drugs, biotech/biosimilars, biologics, and combination products.

Differentiator

Problem solved

Functional benefit

Products and services

• Chemistry, Manufacturing, and Controls (CMC) Regulatory Consultation Expert guidance on CMC section (CTD Module 3) preparation for IND, NDA, BLA, and DMF submissions to FDA, including documentation review, regulatory strategy development, and FDA meeting preparation, targeted at pharmaceutical, biotechnological, and biological drug product companies.
• Regulatory Compliance Services GMP audits for suppliers, manufacturers, and distributors; assessment of regulatory compliance status; and regulatory action remediation for 483 observations, warning letters, and consent decrees, for pharmaceutical, biotech, and biological product manufacturers.
• Quality Assurance / Quality Systems Quality assurance services including development, implementation, and conduct of quality systems for pharmaceutical, biotechnological, and biological sterile injectable drug products.
• Project & Crisis Management Crisis management and project management services for regulatory action remediation situations, including FDA regulatory action response and prevention for pharmaceutical and biotech companies.
• Training Services Professional training on regulatory authority inspections, FDA meeting preparation, and Good Manufacturing Practice (GMP) regulations for pharmaceutical industry professionals.
• US Agent Services for Foreign Manufacturers Acting as US Agent to foreign API and drug/biotech/biological product manufacturers and suppliers for regulatory communication and compliance purposes with the U.S. FDA.

Quantifiable outcome

• Successful FDA approval for sNDA applications with on-schedule product launches
• +1 more outcomes

Named customers3 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

Partnerships

Two partnerships are on record, tiered minor and core.

• University of California, Berkeley Regulatory Affairs Extension ProgramminorOthers · 1 January 2018Dan Klassen serves as instructor for professional and career development courses including Principles of Regulatory Affairs, BLA/NDA/MAA submissions, CMC Regulatory Compliance, and other pharmaceutical regulatory topics.
• NSF InternationalcoreStrategic or Co-development Partner · 1 January 2015Dan Klassen serves as Chairman of the Joint Committee Global Retailers and Manufacturers Alliance (GRMA) for establishment of NSF/ANSI Standard 455-4 for Good Manufacturing Practices for OTC Drugs. The joint committee combines retailer and regulatory requirements into a single standard and auditing program. Klassen also serves as Liaison Member of NSF International Council of Public Health Consultants.

Scale indicators5 records

Recent moves4 records

Expansion highlights3 records

Broad incumbents

• Parexel International: Parexel is one of the largest global CROs offering regulatory affairs, CMC, cGMP, and clinical services to pharma and biotech. Dan Klassen previously served as a Principal Consultant at PAREXEL Consulting, making it a direct capability peer and former employer — they compete for the same CMC and cGMP consulting mandates, but Parexel delivers at far greater scale.
• IQVIA: IQVIA is one of the largest global life sciences services firms offering regulatory, CMC, quality, and compliance consulting alongside clinical and commercial services. It is a broad incumbent competitor for enterprise regulatory mandates that might otherwise go to boutique firms like Klassen Consulting.

Direct peers

• Biologics Consulting Group: Biologics Consulting Group is a regulatory affairs and product development consultancy focused on biologics, vaccines, and cell/gene therapies, supporting IND/BLA filings and FDA interactions. It directly competes with Klassen Consulting for biotech and biological product regulatory mandates.
• Lachman Consultant Services: Lachman Consultant Services is an independent regulatory and compliance consultancy specializing in FDA-related matters, cGMP, CMC, and pharmaceutical quality systems. It is a highly direct peer to Klassen Consulting, targeting similar pharma/biotech clients with similar advisory services.
• The FDA Group: The FDA Group is a regulatory and quality consulting firm providing FDA compliance, cGMP auditing, CMC, and regulatory affairs services to pharma, biotech, and medical device companies. It directly competes with Klassen Consulting for the same CMC remediation and submission support engagements.
• Compliance Implementation Services (CIS): CIS is a regulatory and quality compliance consultancy serving pharma and biotech clients on GxP, cGMP, and quality systems implementation. It is a direct peer for regulatory action remediation and quality systems work, with a referenced testimonial connection to Dan Klassen via Annette Horner.
• ProPharma Group: ProPharma Group is a regulatory and compliance consulting firm serving pharmaceutical, biotech, and medical device companies with services spanning CMC, cGMP compliance, regulatory submissions, and quality systems. It is a direct peer to Klassen Consulting in the pharma regulatory consulting niche, with a broader resource base.
• Pharmatech Associates: Pharmatech Associates is a consulting firm specializing in GMP compliance, CMC, validation, and quality systems for pharmaceutical and biotech manufacturers. It is a direct peer in the cGMP audit and remediation space where Klassen Consulting competes.

Emerging players

• RegDesk: RegDesk is a technology-enabled regulatory affairs platform that helps pharma and biotech companies manage submissions and compliance workflows. It represents an emerging, partially overlapping alternative to traditional CMC consulting, with potential to disintermediate portions of Klassen's service offering over time.

Others

• NSF International: NSF International is a global public health and standards organization where Dan Klassen chairs the GRMA committee establishing NSF/ANSI Standard 455-4. While not a direct competitor, NSF operates in adjacent standards-setting and auditing services that intersect with Klassen Consulting's cGMP audit and compliance offerings.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/pub/dan-klassen/7/5b2/979

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Klassen Consulting