Our Services
Natural Health Products
What’s included?
Product Licensing (Class I, II, III)
- Full application management from start to submission
- Formula review to ensure safety, quality, and efficacy
- Complete handling of all follow-ups and additional requests from Health Canada
- Label review to meet Natural Health Product (NHP) compliance standards
NHP Site Licensing
- Preparation and submission of your site license application
- Compilation of your GMP (Good Manufacturing Practices) evidence package
- Development of a Quality Assurance Person (QAP) competency package
Dietary Supplements
What’s included?
Structure/Function Claim Notification
- We handle your claim submission to the FDA—accurate, timely, and compliant
FDA Label Compliance Review
- In-depth review to ensure your labels meet FDA formatting and content standards
New Ingredient Listing
- Submission to the Dietary Supplement Ingredient Database to validate novel ingredients
Cannabis Products
What’s included?
Cannabis Site Licensing
- Complete site evidence package
- Good Production Practices (GPP) documentation
- EU-GMP alignment support for international readiness
- OSP-compliant security plan
Application Management
- Full submission of your licensing application
- Rapid resolution of RMIs (Requests for More Information) from Health Canada
Quality Assurance & Personnel
- QAP competency documentation tailored to regulatory expectations
Product Notification & Compliance
- Ingredient listings for medical and recreational products
- Formula submissions aligned with regulatory categories
- Label reviews to meet strict cannabis compliance standards
Medical Devices
What’s included?
Medical Device Establishment License (MDEL)
- Completion and submission of all MDEL application forms
- Preparation of the required site evidence package
- Fast resolution of Health Canada’s additional information requests
Medical Device Licensing (Class I–IV)
- Licensing applications for all device classes
- Evidence packages demonstrating safety, efficacy, and performance
- Development of a compliant Quality Management System (QMS)
- ISO 13485:2016 compliance support through MDSAP audit preparation
- Internal audit execution to identify and close compliance gaps