Your Partner in Global Life Sciences Compliance

Guiding Health and Biotechnology Companies to Regulatory Success

Even the most skilled life sciences companies need support navigating ever-evolving regulations. Think of us as an extension of your team—a dedicated group of consultants driven to help you achieve regulatory excellence and business success. Welcome to our global network of compliance experts, quality auditors, and industry professionals.

Our Journey: From Regional Expertise to Global Reach

Founded with a clear mission to support life sciences companies in navigating the world’s toughest regulatory requirements, Lesirg began with a deep understanding of local regulations. Over time, we’ve expanded our operations across the Americas, Europe, Asia, and the Middle East, providing our clients with the global perspective they need to thrive in a highly regulated environment.

Our offices, located in Montreal, Canada, and the Research Triangle Park in North Carolina, USA, serve as hubs for our multicultural and multilingual consultants. By fostering strategic partnerships with experts worldwide, we ensure seamless project transitions and effective team integration, no matter where your business is located.

Tailored Solutions with Industry-Leading Expertise

At Lesirg, we combine customized service with global regulatory insight, delivering high-quality solutions that meet your unique needs. We take pride in offering the best of both worlds: the flexibility of a personalized consultancy and the comprehensive expertise of a global firm.

From product commercialization to full regulatory compliance, we provide customized strategies that address your specific challenges and ensure your products meet the standards of Health Canada, FDA, EMEA, WHO, and more.

Why Work With Us?

Proven Results & Regulatory Mastery

We are results-driven and committed to ensuring your compliance success. Our expert team leverages a deep understanding of regulatory requirements to deliver tangible outcomes that support your business growth and mitigate risk.

Personalized Service & Collaboration

Every client is unique, and we tailor our services to fit your specific needs. We work closely with your team to ensure smooth communication, clear processes, and shared goals, fostering a collaborative environment that brings your vision to life.

Seamless Global Experience

With Lesirg, you can expect a stress-free journey from consultation to implementation. We handle the complexity of global regulatory standards, making the process as seamless as possible so you can focus on what matters most: innovation and growth.

What our clients say about us

Audits

We have contracted Lesirg to conduct audits and site assessments at our high profile and high-risk suppliers and contract manufacturers in North America, Latin America and Europe. Their auditors were highly skilled professionals, they understood our needs based on our products and process complexities, and often helped us adjust and focus the scope of our audits. They were able to work and provide reports in English, French, and Spanish based on our suppliers’ local language. They have worked closely with us and with our suppliers to resolve outstanding issues. They are our auditing partner of choice.

A US-based multinational manufacturer of drug products and medical devices.

QMS Design & Implementation

We were referred to Lesirg when we decided to commercialize our sterile products in Canada. We needed consultants who understand sterile manufacturing and have the best insights on how to work with Health Canada in a compliant manner.
Lesirg developed the entire QMS for our Canadian affiliate, secured all the required licenses and assumed responsibilities of the quality department, hosted Health Canada inspections and helped us hire and train outstanding personnel.
If you are a non-Canadian pharmaceutical company looking to sell your products in Canada, or simply seeking assistance on how to navigate Health Canada’s specific requirements, let Lesirg assist you, you will not be disappointed.

A European manufacturer of sterile drug products

Post-Inspection remediation

Having been audited by a Lesirg consultant on behalf of one of our clients in the past, we reached out to their firm when we needed support addressing inspection observations following a joint regulatory audit. Lesirg helped us understand Health Canada’s specific approach and interpretation to GMPs, especially as they relate to aseptic manufacturing. They helped us develop a comprehensive corrective action plan and were able to move from an NC status to a Conforming status at the subsequent inspection. Thank you to Lesirg who helped us achieve our goal.