Vericert

Health Canada Regulatory Consulting Services

We provide end-to-end Health Canada regulatory consulting services for Indian and global manufacturers looking to export medical devices, pharmaceuticals, APIs, excipients, packaging materials, cosmetics, and food products to Canada. Our services ensure compliance with Health Canada regulations and smooth approval support through the correct regulatory pathway.

Our Health Canada Services Include
1. Medical Device Licensing MDEL and MDL

Health Canada Medical Device License support for Class I II III and IV devices

Manufacturer Distributor and Importer Licensing

Device classification and regulatory pathway assessment

Application preparation submission and follow up

2. Drug Regulatory Support

Support for New Drug Submission NDS ANDS and SNDS

Regulatory strategy and documentation guidance

Coordination with Canadian applicants and partners

3. Drug Master File DMF Services

Type I Active Substance DMF

Type III Packaging Material DMF

Type IV Excipient DMF

DMF preparation conversion from US FDA format

Letter of Authorization support

4. Packaging Material Compliance

Blister foil strip foil and primary packaging DMF support

Extractables and leachables strategy

Pharmacopeial compliance review USP EP BP

5. Establishment Licensing and Compliance

Health Canada establishment licensing support where applicable

GMP and quality system readiness support

ISO 13485 and ISO 15378 guidance

6. Health Canada Cosmetic Notification

Cosmetic Notification Form submission

Ingredient compliance review

Label review as per Canadian regulations

7. Food and Natural Health Product Support

Natural Health Product NHP licensing support

Product license and site license guidance

Compliance with Canadian labeling and ingredient rules

8. Regulatory Gap Analysis and Audit Support

Health Canada regulatory gap assessment

Documentation review and compliance mapping

Pre audit and inspection readiness support

Industries We Serve

Medical Device Manufacturers

Pharmaceutical and API Manufacturers

Packaging Material Manufacturers

Cosmetic and Personal Care Companies

Food and Nutraceutical Exporters

Why Choose Us

Experienced Health Canada regulatory experts

Practical and cost effective solutions

Strong documentation and regulatory justification

End to end support from planning to approval

Support for Indian exporters entering Canada