What RegPharm Consulting Inc. does

RegPharm Consulting Inc. is a privately held, Montreal-based regulatory affairs consulting firm founded in 2003 by Dr. Katia Betito, Ph.D. The company provides Health Canada submission and regulatory strategy support to pharmaceutical, biotechnology, natural health product, cosmetic, and medical device companies seeking Canadian market authorization. Its service portfolio spans eight offerings: preparation and filing of regulatory submissions (Clinical Trial Applications, New Drug Submissions, Supplemental New Drug Submissions, Abbreviated New Drug Submissions, post-approval amendments, natural health product license applications, medical device licences, and cosmetic notifications), regulatory submission strategy and pre-submission meetings, product monograph and labeling preparation, regulatory gap analysis of US or European dossiers for Canadian suitability, due diligence on regulatory documentation prior to acquisitions, post-approval compliance and provincial formulary submissions, clinical and medical writing, and regulatory training courses.

The firm's underlying capability is human-expert domain knowledge rather than technology or platform infrastructure. Dr. Betito, who holds a Ph.D. in Pharmacology and Therapeutics from McGill University, brings over 30 years of regulatory affairs experience including executive roles at Sabex Inc. (now Sandoz) and Paladin Labs Inc., combined with active participation in the Canadian Association of Professional Regulatory Affairs (CAPRA). The company operates as a founder-led consultancy with 1-10 employees, serving the Canadian market exclusively, and has no disclosed subsidiaries, partnerships, funding rounds, or technology platform. Pricing is quote-based and project-scoped, with no public pricing schedule.

The business model is straightforward professional services revenue: clients engage RegPharm on a project or consulting basis for defined regulatory deliverables, and the firm bills against scope. Go-to-market is sales-led direct outreach, with the company website as the primary marketing channel. There is no recurring subscription, software-as-a-service, or transactional revenue component. The firm has maintained continuous independent operations since 2003 with no institutional investment, external ownership, or M&A activity disclosed.

Name

RegPharm Consulting Inc.

Legal name

RegPharm Consulting Inc.

Website

https://regpharmconsulting.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

1–10 employees

Short description

RegPharm Consulting Inc. is a Montreal-based regulatory affairs consulting firm founded in 2003 that advises pharmaceutical, biotech, natural health product, cosmetic, and medical device companies on Health Canada product registration, submissions, and compliance.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Regulatory Compliance Management (RegTech) (BPAEAPAB)

akta.pro secondary industry

Licensing, Registration & Fit-and-Proper Compliance (FSAFAOAO)

Keywords

• Regulatory affairs consulting
• Health canada submissions
• Pharmaceutical regulatory services
• Medical device licensing
• Clinical trial applications

Headquarters

HQ city

Montreal

HQ country

Canada

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 Affairs Consulting Services: Professional consulting services provided to companies seeking regulatory approval for their products in Canada. Services include preparation and filing of regulatory submissions, regulatory strategy development, pre-submission meetings, due diligence, and compliance activities.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

RegPharm Consulting Inc. is a full-service regulatory affairs consulting firm that assists pharmaceutical, biotechnology, natural health product, cosmetic, and medical device companies with registration of products with Health Canada. Founded in 2003 and based in Montreal, the firm provides preparation and filing of regulatory submissions, regulatory strategy, gap analysis of US/EU dossiers, due diligence, product monograph and labelling services, post-approval compliance, clinical and medical writing, and regulatory training courses.

Product overview

RegPharm Consulting Inc. is a full-service regulatory affairs consulting firm offering a unified portfolio of consulting services to assist pharmaceutical, biotechnology, natural health product, cosmetic, and medical device companies with the Canadian regulatory approval process. The company provides eight distinct but complementary service offerings: Regulatory Submission Preparation and Filing Services (covering drugs, biologics, natural health products, cosmetics, and medical devices); Regulatory Submission Strategy and pre-submission meeting facilitation; Product Monograph and Labeling Services; Regulatory Gap Analysis for US/EU dossiers; Due Diligence of regulatory documentation; Regulatory Compliance and Post-Approval Services; Clinical and Medical Writing; and Regulatory Training Courses. Founded in 2003 and led by Dr. Katia Betito with over 30 years of regulatory affairs experience, the firm serves as an intermediary between sponsors and Health Canada.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Submission Preparation and Filing Services
• Regulatory Submission Strategy and Pre-Submission Meetings
• Product Monograph and Labelling Services
• Regulatory Gap Analysis
• Due Diligence Services
• Regulatory Compliance and Post-Approval Services
• Clinical and Medical Writing Services
• Regulatory Training Courses

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators2 records

Recent moves4 records

Broad incumbents

• ICON plc: Global CRO providing clinical, regulatory, and laboratory services to pharma/biotech sponsors. Comparable as a broad regulatory services provider for Health Canada submissions bundled with global clinical development offerings.
• Parexel: Major global CRO offering clinical research, regulatory affairs, and commercialization services across drugs, biologics, and devices. Comparable as a regulatory services provider for Health Canada and global submissions, with bundled full-service clinical/regulatory offerings.
• PharmaLex: Global regulatory and compliance consulting firm offering regulatory affairs, pharmacovigilance, and quality/compliance services to pharma and biotech clients. Comparable as a broader regulatory consultancy serving overlapping pharma clients, with deeper multi-jurisdictional coverage.
• Charles River Laboratories: Global CRO providing preclinical, clinical, and regulatory consulting services for drug development. Comparable as a broader regulatory services provider serving pharma and biotech sponsors with established products in market.
• Catalent: Global CDMO and pharma services provider offering drug development, manufacturing, and regulatory support across multiple dosage forms and biologics. Comparable as a broader pharma services partner that includes regulatory affairs support for sponsors targeting multiple markets.
• IQVIA: World's largest CRO with integrated regulatory, clinical, and commercial services for pharma/biotech. Comparable as a broad regulatory services provider for Health Canada and global submissions, with bundled technology and data assets.
• WuXi AppTec: Global CRO/CDMO offering drug discovery, development, manufacturing, and regulatory services across small molecules, biologics, and devices. Comparable as a broader regulatory services provider for international pharma sponsors, including Canadian market access.

Direct peers

• Veristat: Regulatory and clinical consulting firm specializing in regulatory submissions, clinical development, and biostatistics for therapeutic products. Directly comparable as a regulatory affairs-led consultancy serving similar pharma/biotech sponsors, with broader clinical capabilities.
• NDA Group: Global regulatory affairs consulting firm offering regulatory strategy, submission preparation, and lifecycle management services for drugs, biologics, and medical devices. Directly comparable as a specialist regulatory consultancy serving similar pharma/biotech clients, though NDA operates at much larger scale and across multiple jurisdictions.

Regional players

• PharmEng International: Canadian pharmaceutical consulting firm providing regulatory affairs, quality, and compliance services to pharma clients in Canada. Directly comparable as a domestic Canadian regulatory consultancy serving similar pharma/biotech clients seeking Health Canada expertise.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/regpharm-consulting-inc

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 RegPharm Consulting Inc.