Assurance au cœur du Québec

Quality systems that surpass GMP obligations

Our Canadian site aligns with Health Canada, FDA, EMA, and ISO frameworks—delivering trusted biologics with zero critical findings.

GMP wall Document centre Supplier integrity ESG & sustainability

Global certification wall

Inspection milestones and certificates are curated in our digital trust centre, accessible to partners in English and French.

Health Canada (MDEL & DEL)

Licence No. 10245 renewed 2024 with commendation on digital deviation tracking.

U.S. FDA

Biologics licence operations inspected 2023—no Form 483 observations issued.

EMA / ANSM Mutual Recognition

EU GMP certificate (FR/EMA/PI/145) sustained with yearly remote review.

ISO 13485 & ISO 17025

Integrated management system audited by CSA Group with zero major non-conformities.

GAMP 5 & Annex 11 validation

Computerised systems verified for data integrity, audit trails, and bilingual access.

Occupational health & biosafety

CSA Z1000 and WHMIS compliance covering biosafety level 2 laboratories.

Quality document centre

Authorised partners can download bilingual SOPs, batch records, and certificates through secure identity management.

Document	Language	Access
Plasma fractionation master batch record	EN / FR	Request via portal
Deviation & CAPA procedure	EN / FR	Request via portal
Supplier qualification checklist	EN / FR	Request via portal
Annual product review summary	EN / FR	Request via portal

Supplier integrity and scorecards

Continuous monitoring safeguards plasma inputs, reagents, and logistics partners.

Qualification & onboarding

Risk-based audits evaluate GMP alignment, sustainability, and bilingual documentation.

Scorecard rating • 92/100

Environmental, social & governance (ESG)

We embed sustainability and community commitments within our GMP framework.

43% renewable electricity powering the Laval site

52% women represented across leadership roles

19% waste diversion improvement since 2021

0 lost-time incidents in the past 36 months