Canadian Regulatory Strategy & Commercialization

Regulatory strategy built for commercial execution.

Baseline Co. helps natural health, food and wellness companies navigate Canadian requirements and prepare products for compliant commercial manufacturing.

From product classification and licensing through formulation, packaging and production readiness, Baseline connects the regulatory decisions to the practical work required to move forward.

Supporting start-ups and scaling brands international companies entering Canada manufacturers and licensed facilities.

Where are you in the process?

The right support depends on what you are developing, where the project stands and what must happen next.

01

Building or scaling a product

For natural health, food and wellness companies working through classification, formulation, licensing, labels, manufacturing or launch preparation.

Support for Brands
02

Entering the Canadian market

For international companies that need to determine how a product must be adapted for Canada before investing in submissions, reformulation, packaging or market-entry execution.

Canadian Market-Entry Support
03

Operating a regulated facility

For manufacturers and licensed facilities requiring practical support with regulatory submissions, documentation, GMP systems and production-related compliance.

Manufacturer Support

Why the early decisions matter

Regulatory compliance does not happen in isolation.

Product classification affects which ingredients, claims and licensing pathways are available. Formulation decisions affect manufacturing feasibility. Packaging choices determine whether required information can be presented properly on the finished product.

When these workstreams are handled separately, or in the wrong order, companies can lose time, repeat completed work and invest in a pathway that was never properly validated.

Baseline connects regulatory requirements to the practical decisions involved in developing, manufacturing and commercializing a product.

01

Classification

Determines the regulatory pathway and the requirements that follow.

02

Ingredients, dose and claims

Shape product feasibility, evidence needs and what can appear on the label.

03

Packaging and manufacturing

Create real constraints around mandatory information, equipment, production and launch timing.

Support built around what needs to happen next.

Some projects need a regulatory determination. Others need focused implementation or coordination across several workstreams. Baseline structures each engagement around the actual problem, not a predetermined package.

01

Define the pathway

For projects where classification, ingredient feasibility, claims or Canadian requirements remain uncertain.

  • Product classification
  • Regulatory feasibility
  • Canadian market-entry assessment
  • Ingredient, dose and format review
  • Recommended pathway and next steps
Explore Regulatory Strategy
02

Prepare the product

For products moving through formulation, licensing, label development or artwork review.

  • NHP licensing and submissions
  • Food and supplemented-food compliance
  • Formulation and claims review
  • Mandatory label-copy requirements
  • Artwork-stage compliance review
Explore Product Compliance
03

Coordinate commercialization

For companies coordinating product development, manufacturers, packaging and production readiness.

  • Manufacturer identification and coordination
  • R&D and sample-round coordination
  • Commercial-manufacturing readiness
  • Production and packaging dependencies
  • Cross-party project coordination
Explore Commercialization Support

When the pathway is uncertain

Answers before implementation estimates.

When product classification, ingredient feasibility or the intended regulatory pathway has not been established, implementation cannot be scoped responsibly.

A focused assessment identifies the viable route, material constraints and decisions that must be made before further investment. Once that foundation exists, Baseline can define the next phase with reliable deliverables, responsibilities and pricing.

The objective is not to create an unnecessary preliminary phase. It is to prevent you from investing further in a pathway that has not been properly validated.

  • Applicable product classification
  • Ingredient, dose and format constraints
  • Viable regulatory pathway or options
  • Claims and labelling implications
  • Recommended next steps
  • Basis for an implementation proposal
Discuss an Assessment

Founder-led expertise

Regulatory knowledge informed by operating experience.

Mike WallisFounder, Baseline Co.

Regulatory advice becomes far more useful when it accounts for what happens next: supplier constraints, equipment capabilities, packaging limitations, production timelines, commercial pressure and the realities of building a business.

I built Baseline to close the gap between regulatory advice and practical execution.

Nearly a decade working in compliance at TD gave me a foundation in controls, accountability, audit readiness and systems designed to withstand scrutiny.

As a co-founder of Tenfed, I experienced what it means to build and operate a company, make decisions with limited resources and move work forward without large-company infrastructure.

I later worked directly in functional-product development and manufacturing, developing formulations, sourcing equipment, supporting facility development, managing production, building GMP systems and completing Health Canada licensing work.

That combination allows me to see both sides of a project: what the regulatory pathway requires and what it will take to execute commercially.

Learn About Mike

Selected experience

Work grounded in real regulatory and operating constraints.

Representative examples are anonymized to protect confidential business and product information. They reflect regulatory work and operating experience, not guaranteed outcomes.

01

Supplemented-food artwork under production pressure

Reviewed formulation-driven label requirements and finished-package constraints, identified type-size and available-space issues before print, and defined the changes required for a defensible production decision.

02

Canadian pathway validation before filing

Assessed product format, ingredients and intended claims where the requested licensing route was uncertain, separating the viable Canadian options from work that would have committed the company to the wrong pathway.

03

Functional-product manufacturing operations

Connected formulation, equipment sourcing, facility development, production management, GMP systems and Health Canada licensing work within a commercial manufacturing environment.

Client perspective

Confidence built through careful work.

Working with Michael on our labelling review was exactly what you want from a regulatory consultant. He was responsive and quick, but never at the expense of thoroughness. He walked us through the Health Canada compliance process and kept the project on timeline without cutting corners. His attention to detail and depth of knowledge gave us real confidence throughout. We highly recommend Baseline Co. to both new and established brands looking for reliable regulatory support.

Head of Production & Quality, from Natales Ltd

Working with Mike on the Still In It project was seamless from start to finish. He was exceptionally prompt and thorough, and went above and beyond by putting in overtime to keep us on track through a tight turnaround. Thanks to this, we were able to finalize and send our labelling design to packaging right before the deadline without missing a beat.

Randy - Unfinished Series Founder

How engagements work

A defined way forward.

01

Understand the situation

Baseline reviews the product or operation, current stage, objectives and known constraints to determine whether the project appears to fit.

02

Define the engagement

The appropriate next step may be a pathway assessment, a focused implementation scope or broader commercialization support. Deliverables, responsibilities, dependencies and fees are established before work begins.

03

Execute and coordinate

Baseline completes the agreed regulatory work and coordinates the relevant parties where included in scope, keeping decisions and deliverables connected as the project advances.

Not every inquiry requires an end-to-end engagement. The scope should match the problem.

Professional memberships

Connected to Canada's natural product and health food communities.

Baseline Co. is a member of Natural Products Canada and an Associate Member of the Canadian Health Food Association.

Active CAPRA MemberAAPS Natural Health Product Regulatory TrainingCanada-Focused Regulatory SupportDirect Founder Involvement

Start the conversation

Tell me what you are trying to bring to market, or what is holding it back.

Whether you are developing a new product, entering Canada, preparing a submission, revising packaging or addressing a manufacturing-compliance issue, start by describing the situation.

I will review the information, determine whether the project appears to fit and respond with a recommended way forward.

Discuss Your ProjectPlease do not submit confidential formulations or sensitive proprietary information through the initial inquiry. Secure document exchange can be arranged if required.