Nor Consult

What Nor Consult does

Nor Consult, LLC is a Seattle-based contract research organization (CRO) and regulatory consulting firm founded in 2005 by Dr. Branko Kopjar, a University of Washington emeritus faculty physician-researcher and clinical epidemiologist. The firm provides clinical research services across medical devices, drugs, and combination products, organized into two product lines: Clinical Research Solutions (biostatistics and programming, clinical study design, clinical epidemiology, EDC-based data management, imaging core lab integration, safety management, and medical writing) and Consulting & Strategy Solutions (regulatory affairs for FDA, EMA, EU MDR/IVDR, Health Canada, and TGA pathways, biometrics consulting, investor due diligence, and expert witness testimony). The underlying technology stack is centered on CDISC-compliant datasets, EDC systems, and SAS/R/Python statistical programming rather than proprietary software.

The firm operates as a professional services boutique on a direct-engagement, quote-based model. Clients enter through a Request for Proposal process and work directly with senior scientists, biostatisticians, and clinicians — including Senior Scientific Advisor Dr. Patrick Heagerty (National Academy of Medicine member and JAMA statistical editor) — rather than through a layered staffing pyramid. Target customers are mid-sized medical device manufacturers, emerging biotechs, established pharmaceutical companies, and academic/non-profit research sponsors running complex trials in cardiovascular, neurovascular, orthopedic/spine, wound/infectious disease, and oncology therapeutic areas. Named enterprise customers include Hip Innovation Technology, Convatec Group, Zetagen Therapeutics, Cerapedics, and AO Foundation, with documented regulatory outcomes including a PMA approval for Cerapedics' P-15 orthobiologic.

The firm is founder-owned (Managing Member Dr. Kopjar) and has grown organically without disclosed external funding. It serves a global client base spanning the United States, Canada, Europe, Australia, and China from a single Seattle headquarters at 677 Strander Blvd, Suite F. The business is supported by a 10+ investigator expert network profiled on its website and by long-tenured collaborations (15+ years) with senior physician-researchers such as Dr. Michael Fehlings and Dr. Paul Arnold. Headcount is in the 11-50 range, and revenue is not publicly disclosed.

Name

Nor Consult

Legal name

Nor Consult, LLC

Website

https://nor-consult.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Nor Consult is a Seattle-based CRO and regulatory consulting firm providing clinical research, biostatistics, data management, and FDA/EMA submission support for medical device, drug, and combination product sponsors across cardiovascular, orthopedic, oncology, and wound care indications.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Management Consulting Services (54161)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAGAAAL

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAH

Pharmacovigilance, Risk Management & Medical Affairs CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGACAE

Clinical Trial Site Operations & Study Coordination

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Clinical Trial Services & Site Management (SMO)

Keywords

• Clinical research services
• Medical device trials
• Biostatistics consulting
• Regulatory affairs
• Drug development support

Headquarters

HQ city

Seattle

HQ country

United States

HQ region

North America

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. Clinical Research Services: End-to-end CRO services including trial design, execution, clinical monitoring, data management, biostatistics, and regulatory submissions for drugs, devices, and combination products.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Nor Consult is a specialized CRO and regulatory consulting firm providing end-to-end clinical research services and regulatory strategy support for medical devices, drugs, and combination products. Its Clinical Research Solutions span biostatistics and programming, clinical study design, clinical epidemiology, data management, imaging and core labs, safety management, and medical writing. Its Consulting & Strategy Solutions cover FDA, EMA, Health Canada, EU MDR/IVDR, and TGA regulatory pathways, biometrics consulting, investor strategy, and expert witness services.

Product overview

Nor Consult offers two interconnected service portfolios: Clinical Research Solutions provides end-to-end CRO services spanning biostatistics & programming, clinical study design, clinical epidemiology, data management, imaging & core labs, safety management, and medical writing; Consulting & Strategy Solutions provides regulatory strategy consulting (FDA, EU MDR/IVDR, Health Canada, TGA), biometrics services, investor due diligence, and expert witness testimony. Together these services support sponsors from trial design through global regulatory approvals.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Research Solutions End-to-end clinical research services for sponsors of drugs, medical devices, and combination products, covering biostatistics and programming, clinical study design, clinical epidemiology, data management, imaging and core labs, safety management and reporting, and medical writing and publications.
• Consulting & Strategy Solutions Strategic consulting services covering regulatory affairs (FDA IDE/PMA, NDA/BLA, EU MDR/IVDR, Health Canada, TGA), biometrics and clinical epidemiology advisory, investor strategy and due diligence, and expert witness testimony.

Quantifiable outcome

• Successfully supported multiple FDA and global regulatory approvals
• +2 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Medpace: Mid-sized, therapeutically-focused CRO with deep biostatistics and clinical operations capabilities. Directly comparable to Nor Consult in its focus on complex trials in cardiovascular, oncology, and medical devices, though operating at materially greater scale.
• Inotiv: Contract research services organization providing preclinical and clinical research support to medical device and pharmaceutical sponsors. Comparable to Nor Consult in serving device/pharma sponsors with research execution and data analysis services.
• Premier Research: Specialty CRO focused on small-to-mid biotech, rare disease, and medical device trials with strong biostatistics and regulatory capabilities. Closely comparable to Nor Consult in serving small and emerging device/pharma sponsors with high-touch engagement models.
• Veristat: Specialty clinical research and biostatistics firm supporting FDA/EMA regulatory submissions for drugs and devices. Highly comparable to Nor Consult's consulting-plus-biometrics service profile, especially for FDA-ready deliverables.
• Clinipace Worldwide: Mid-sized full-service CRO offering clinical operations, biostatistics, and regulatory services for emerging biotech and device sponsors. Closely comparable in customer segment and service scope.
• Worldwide Clinical Trials: Mid-sized specialty CRO offering biostatistics, clinical operations, and regulatory consulting across cardiovascular, neuroscience, and rare disease — directly overlapping Nor Consult's cardiovascular, neurovascular, and specialty therapeutic focus.

Broad incumbents

• IQVIA: Largest global CRO with extensive clinical operations, biostatistics, and regulatory services. Competes with Nor Consult for the same enterprise medical device and pharma sponsors but with vastly broader capabilities.
• Clario (formerly Bioclinica): Clinical trial technology and services provider with strong imaging core lab and EDC capabilities. Overlaps with Nor Consult's imaging core lab and EDC build features and competes for the same device trial sponsors.
• ICON plc: Large full-service CRO with broad therapeutic coverage and global operational scale. Overlaps with Nor Consult's CRO services but at substantially greater scale and geographic breadth.

Emerging players

• Linical Accelovance: Specialty CRO focused on oncology, neuroscience, and rare disease with deep Asia-Pacific presence. Comparable to Nor Consult in therapeutic specialization but with broader geographic coverage in Japan and Asia.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Nor Consult