Our Regulatory Services

Comprehensive FDA and Health Canada compliance solutions tailored to your product category.

Medical Devices

510(k) and De Novo submissions, UDI compliance, Health Canada MDL/MDEL, and Quality Management Systems.

MoCRA facility registration, product listing, labeling compliance, Health Canada CNF, and ingredient review.

OTC monograph compliance, Drug Facts labeling, cGMP audits, and establishment registration.

DSHEA compliance, NDI notifications, FSMA Preventive Controls, cGMP audits, supplement labeling, and Health Canada NHP product licences.

FDA Initial Importer programs, Prior Notice filing, import alert resolution, and FDA-registered warehousing.

Book a free 30-minute consultation to discuss your regulatory needs and get a custom roadmap.