RegulaWise is an independent regulatory affairs and quality consulting firm supporting life sciences companies across global markets.

We work with medical device, pharmaceutical, biotechnology, and veterinary product manufacturers to deliver practical, risk-based regulatory and quality solutions aligned with regulatory expectations and business objectives.

Our experience spans established and emerging regulatory environments, supporting product development, market authorization, and lifecycle compliance activities.

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Explore Our Services

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We take a structured, risk-based approach to regulatory and quality consulting, aligning regulatory expectations with practical implementation. Our focus is on clarity, defensibility, and efficient execution across global markets.

Risk-based and regulator-aligned
Practical and execution-focused
Scalable across global markets

RegulaWise is based in Canada and supports clients across North America, Europe, Asia-Pacific, the Middle East, and other global markets.

Our services are delivered remotely and on-site through coordinated engagement with clients and partners worldwide.

Primary Base

CANADA

Remote and project-based on-site support

Service Model

A world map highlighting Canada, the US, Europe, and international markets served by Regulawise.

FAQs

What services do you offer?

We provide regulatory affairs and quality consulting services, including regulatory strategy, market authorization support, quality management systems, post-market compliance, and lifecycle management across global markets.

Which markets do you cover?

We support clients in Canada, the United States, the European Union, and a range of international markets including Asia-Pacific, the Middle East, and other emerging regulatory environments.

Who are your typical clients?

We primarily work with small and mid-size medical device, pharmaceutical, biotechnology, and veterinary product manufacturers seeking practical regulatory and quality support.

How do you approach compliance?

We apply a structured, risk-based approach tailored to each product and target market, aligning regulatory expectations with practical implementation and defensible decision-making.

Can you support post-market and lifecycle activities?

Yes. We support post-market regulatory obligations, change management, audits, and ongoing compliance activities throughout the product lifecycle.

How do you ensure efficient market entry?

By combining regulatory insight with quality system alignment, we help clients plan and execute market entry strategies in a structured and regulator-aligned manner.