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Earning client trust, through quality and excellence
Regulatory Affairs and Quality Team
We are a Regulatory Affairs and Quality Assurance Consulting Firm, providing complete business solutions to companies looking to import, distribute, manufacture, and market healthcare products in Canada. Our expertise ensures compliance with regulatory requirements, streamlining the process for businesses to successfully enter and thrive in the Canadian healthcare market.
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Services
We help our clients with best Consultation strategy
Why Choose Us?
Our team specializes in securing regulatory approvals and ensuring quality compliance for healthcare products in the Canadian market. We are committed to delivering comprehensive regulatory and quality strategies that align with Health Canada’s stringent requirements, guiding your product through every stage of its lifecycle with precision and expertise.
QUESTION ANSWERS
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We provide comprehensive Regulatory Affairs and Quality Assurance consulting, including Health Canada approvals, GMP compliance, import/export licensing, and market entry strategies for healthcare products in Canada.
Our team specializes in regulatory submissions, licensing applications, and compliance strategies to ensure your product meets Health Canada’s requirements, from Natural Health Products (NHPs) to pharmaceuticals and medical devices.
We assist with prescription drugs, over-the-counter (OTC) medicines, natural health products (NHPs), medical devices, and cosmetics, ensuring regulatory compliance for smooth market entry.
Approval timelines vary based on product type and Health Canada’s review process. On average, NHP approvals take 3-6 months, while prescription drug approvals may take 12-24 months.
Yes, we offer GMP consulting, facility audits, and compliance strategies to ensure your manufacturing processes meet Health Canada and international quality standards.
- A Medical Device Establishment License (MDEL)
- We assist with the application process and compliance .
- We guide you through the licensing process.
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Welcome to WordPress. This is your first post. Edit or delete it, then start writing!
Hello world!
Welcome to WordPress. This is your first post. Edit or delete it, then start writing!