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By - Kossi Molley (he/il)

Understanding Health Canada’s New Draft GMP Guide for Natural Health Products

Health Canada has released a new Draft Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs), marking a significant update in the regulation of supplements, herbal remedies, vitamins, and other natural health products in Canada. If you’re a manufacturer, distributor, or consumer of NHPs, this draft guide is worth paying attention to—it could shape

By - Kossi Molley (he/il)

White Paper: Decoding the Regulatory Maze for Biotech Innovation

In today’s rapidly evolving biotechnology landscape, regulatory challenges often determine the difference between groundbreaking innovations that reach patients and those that remain trapped in development limbo. We’re excited to announce the release of our comprehensive white paper, “Navigating the Regulatory Landscape: 10 Critical Challenges for Biotech Companies,” designed to help innovators chart a successful course

By - Kossi Molley (he/il)

GMP Quality Compliance and the Role of AI in Biopharmaceuticals

Good Manufacturing Practice (GMP) quality compliance is a cornerstone of the biopharmaceutical industry, ensuring that products are consistently produced and controlled according to high standards. As artificial intelligence (AI) and machine learning (ML) find increasing applications across the sector, it’s essential to consider how quality management processes need to evolve. Incorporating AI into biopharmaceuticals can

By - Kossi Molley (he/il)

Choosing the Right Tool for the Quality Job: 6 Key Considerations for Your Quality Management System

Choosing the right QMS is an investment in your organization’s future. By carefully considering these factors, you can select a system that empowers your quality goals, streamlines operations, and sets you on the path to continuous improvement.

By - Kossi Molley (he/il)

Keeping health product safe in Canada

Keeping health products safe means ensuring that the product lifecycle are implemented and in control. The health product lifecycle here refers to all stages in the pre- and post-market “life” of a health product. According to Health Canada, the stages may include several or all of the following: pre-clinical studies, clinical trials, submission of product