We will assist you with providing all of the requirements and guidance documents for the licensable activity you wish to achieve for the fabrication, packaging/labeling, testing, import, distribution and wholesale of drug products, medical devices and natural health products.
We will review your NDS, ANDS, DEL, MDEL, Site License, MDL, NHP, VHP, Disinfectant Drug, and CFIA dossier documents prior to submission in order to assist in ensuring your submissions are accurate and complete.
Once you have submitted your application to Health Canada or are due for an initial inspection or a re-inspection, we can prepare you for the inspection with a pre-inspection audit. For more information, click here. Follow our blog for more details on GMP inspections during the COVID-19 pandemic and guidance on the upcoming remote GMP inspections.
Need to write SOP's to comply with GMP for your DEL or MDEL? We provide full SOP drafting and review services.
Are you in need of a fully Health Canada compliant label for your product? We are able to provide draft bilingual compliant product labels.
Does your corporation require ongoing Quality Assurance (QA) but doesn't have the budget for a full-time QA Manager? If so, we can provide contract QA management services to meet the needs of your business.
Have a business idea? Whether you're starting a new business, looking to expand your portfolio or enter new markets, we will ensure you're on the right track.
We conduct customized market research and provide strategic planning to assist in establishing the groundwork for your company's product or service launch.
Is your business unsure if you are in compliance with federal, provincial/state or corporate regulations? We can assist you by providing a thorough review of all regulations pertaining to your business.
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