Project Overview

Canada's veterinary diagnostics market represents a $268 million opportunity growing at 9% annually - the fastest-growing segment in Canadian animal healthcare. Despite this growth, regulatory barriers have limited the availability of veterinary rapid tests, creating significant market gaps for point-of-care diagnostics.

We have identified a partnership opportunity with an established international manufacturer that produces over 25 veterinary rapid diagnostic tests for both companion animals and livestock. These rapid tests are successfully marketed globally but have never been submitted for Canadian regulatory approval.

This project will develop a comprehensive market entry strategy and regulatory roadmap to bring these proven veterinary rapid tests to the Canadian market through the Canadian Food Inspection Agency (CFIA) approval process.

The Challenge

The Canadian veterinary diagnostics landscape is fundamentally different from human medical devices. While Abundant Science has deep expertise in Health Canada's regulatory framework for rapid tests, veterinary rapid tests are regulated by CFIA as "veterinary biologics" under completely different legislation and requirements.

Our manufacturing partner has expressed strong interest in the Canadian market but lacks familiarity with CFIA processes for rapid test approval. We need a comprehensive regulatory strategy that identifies:

• Which rapid test products have the highest market potential in Canada
• Specific CFIA approval requirements and timelines for each product category
• Investment requirements and revenue projections for market entry
• Optimal sequencing of product submissions to maximize success

Learning Objectives

Students will gain hands-on experience in:

• International regulatory affairs and market entry strategy
• Primary research methods including stakeholder interviews and market analysis
• Business case development with financial modeling and risk assessment
• Strategic consulting for biotechnology companies
• Cross-border partnership structuring and execution

Ideal Candidate Profile

We're seeking students with:

• Academic Background: Business, Life Sciences, Regulatory Affairs, or related fields (3rd/4th year preferred)
• Research Skills: Strong analytical capabilities and experience with primary research methods
• Communication: Excellent written and verbal communication skills
• Interest Areas: Biotechnology, international business, regulatory affairs, or animal health
• Technical Aptitude: Comfortable working with regulatory documentation and market data

Mentorship & Support

Jay Gerbrandt, Chief Science Officer will provide comprehensive mentorship including:

• Project kickoff session with strategic context and industry insights (2 hours)
• Bi-weekly progress reviews and guidance sessions (4 × 1 hour)
• Access to industry contacts including regulatory consultants and veterinarians
• Final presentation feedback and career development discussion (2 hours)

Resources Provided

• Access to premium market research databases and industry reports
• Introduction to 3-5 regulatory consultants for expert interviews
• Connection to Canadian Animal Health Institute for market data
• Templates for regulatory documentation and financial modeling
• Abundant Science's existing Health Canada regulatory expertise as reference

Industry Impact & Career Development

This project offers exceptional exposure to the rapidly growing animal health industry while developing critical skills in regulatory affairs and international business development. Students will work directly with company executives on a real market entry strategy that could result in bringing life-saving veterinary rapid tests to Canadian animals.

The regulatory affairs and biotechnology sectors offer excellent career prospects, with growing demand for professionals who understand both rapid diagnostic innovation and regulatory compliance. This project provides practical experience that directly translates to opportunities in pharmaceutical, biotech, and medical device companies.

Detailed Scope of Work

Phase 1: Rapid Test Portfolio & Market Analysis (Weeks 1-3)

• Catalog and analyze our partner's complete veterinary rapid test portfolio
• Research Canadian market demand for each rapid test category (companion animals vs. livestock)
• Identify current competitors and pricing for rapid tests in the Canadian market
• Conduct veterinarian surveys to assess unmet rapid diagnostic needs
• Prioritize 5-7 rapid test products with highest Canadian market potential

Phase 2: CFIA Regulatory Pathway Analysis (Weeks 4-6)

• Map CFIA veterinary biologics approval process requirements
• Interview CFIA officials and regulatory consultants specializing in veterinary products
• Analyze successful recent approvals to identify best practices and timelines
• Calculate approval costs, documentation requirements, and critical success factors
• Develop product-specific regulatory submission strategies

Phase 3: Strategic Implementation Plan (Weeks 7-8)

• Create comprehensive business case with revenue projections and investment requirements
• Develop 18-month implementation timeline with milestone-based approach
• Design competitive positioning strategy for each priority product
• Define Abundant Science's role as regulatory consultant and market facilitator
• Present actionable recommendations to company leadership

Expected Deliverables

1. Product Prioritization Matrix: Ranking of all products by Canadian market potential, regulatory complexity, and competitive advantage; Market size estimates and revenue projections for each product category
2. CFIA Regulatory Roadmap: Step-by-step approval process for each priority product, Timeline analysis, cost estimates, and critical success factors, Risk mitigation strategies and contingency planning
3. Market Entry Business Case: Comprehensive financial analysis with 3-year revenue projections, Investment requirements and ROI calculations, Competitive analysis and market positioning strategy
4. Regulatory Consulting Framework: Abundant Science's value proposition as Canadian regulatory partner, Service offering structure and fee arrangements, Long-term partnership development strategy
5. Executive Presentation: Strategic recommendations with clear next steps, Partner-ready presentation for regulatory approval pathway, Implementation timeline with key milestones