ZIGMA PLUS

 

 

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Zigma Plus was founded in 2012 as a consulting business initially providing services for start-up business in the Natural Health Products sector in Canada. Today, Zigma Plus has expanded its business into Food and Cannabis sector and provides a wide variety of services in product formulations, product and facility registrations, labelling reviews and quality system implementation. Our clients include companies located in Canada, USA, and Brazil and varies from small business to consulting firms. 

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From site licence applications to post-market authorizations (ie. NPN), we provide guidance in quality assurance, product and marketing compliance and overall regulatory consulting services in health-related products.    

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Zigma plus is dedicated in providing companies with professional consulting services to ensure regulatory compliance and your company's success. 

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Product Licence (NHP): It could take from 30 to 180 calendar days to have a product licence application (PLA) processed depending on the class of submission. Once approved, a NPN (Natural Product Number) is assigned to the product

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Site Licence (NHP): In order to manufacture, package, label or import NHPs, a site licence issued by Health Canada is required.

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NHP Labelling Review: All NHPs must meet Part 5 of the Natural Health Products Regulations as well as approved proposed label as per product licence issued by Health Canada.

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Foreign Site Reference Application (FSRN): It is recommended that all foreign manufacturers who intend to export product to Canada to obtain a FSRN to ensure compliance with Canadian GMP and facilitate export activities.

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Dietary supplement labelling: All dietary supplement labels must be compliant to FDA, DSHEA and relevant guidance documents.

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SFCR Licence: In order to manufacturer, package, label, import food products a SFCR licence issued by CFIA is required.

 

Food Labelling: Food labelling must comply with the Canadian Food and Drugs Act as well as CFR Title 21 in order to be sold in the Canadian and US market. 

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Cannabis Labelling: Canadian cannabis products must meet Part 7 of the Canadian Cannabis Regulations.

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Quality Management System: NHPs, Foods and Cannabis must meet corresponding cGMP guidance as well as Safe Food for Canadian Regulations.

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