Frequently Asked Questions

We specialize in importing a diverse range of healthcare products to meet the unique needs of our clients. Our portfolio includes Over-the-Counter (OTC) drugs, prescription drugs, vaccines, biologics, Active Pharmaceutical Ingredients (APIs), medical devices, natural health products, and investigational medicinal products. This broad expertise ensures that we can cater to a wide spectrum of healthcare products to facilitate their entry into the Canadian market. For further details on the specific categories we handle, please refer to our Products and Services page.

Certain healthcare products, including pharmaceuticals, natural health products, and medical devices, require specific establishment licenses for importation into Canada. Progress Therapeutics holds key licenses such as the Drug Establishment Licence (DEL), Site Licence (SL), and Medical Device Establishment Licence (MDEL) to ensure compliance with Health Canada regulations for these product categories. please contact our office.

Progress Therapeutics holds essential licenses for importation, including a Drug Establishment Licence (DEL) for pharmaceuticals, a Site Licence (SL) for natural health products, and a Medical Device Establishment Licence (MDEL) for medical devices. These licenses underscore our commitment to regulatory compliance and excellence in importation services. For a detailed overview of our licenses and certifications, please refer to our Credentials section.

Our regulatory experts leverage extensive experience to strategize and efficiently navigate Health Canada's review process, ensuring a swift market entry for your products. We also have a network of strategic partners that can complete all aspects of market entry, such as product licensing, warehousing, pharmacovigilance and testing.

Yes we can. Through our established network of third-party partners, we facilitate comprehensive warehousing and distribution services across Canada. This ensures that your products are efficiently stored and distributed, reaching every corner of the country seamlessly to meet market demands. For more information on our warehousing and distribution capabilities, please visit our Logistics Solutions page.

Our commitment extends beyond initial importation to ongoing quality assurance and regulatory compliance. Progress handles all aspects of QA pertaining to the products that are imported. To understand more about our quality assurance practices, you can explore our Services section.

Our pharmacovigilance partners will tailor their services to your specific needs, offering solutions such as dedicated complaint lines and streamlined adverse event reporting to Health Canada. To delve deeper into our pharmacovigilance services, you can explore our Pharmacovigilance Solutions section.

Yes, our accomplished partners are well-equipped to assist with various regulatory filings, including New Drug Submissions, Over-the-Counter (OTC) Drug Identification Numbers, and Medical Device Licence applications. We provide comprehensive support to navigate regulatory processes successfully. To learn more about our regulatory filing services, please visit our Regulatory Filings section.

You can contact our team through the information provided on our Contact Us page, which includes our phone number, email address, and an inquiry form. We welcome inquiries and are ready to assist you with any questions or concerns you may have.

The importation of healthcare products into Canada from the United States is tightly regulated to ensure safety, efficacy, and quality. Health Canada, the country's federal health authority, plays a pivotal role in creating and overseeing these regulations. The regulatory framework is designed to protect public health by ensuring that all imported healthcare products comply with the stringent standards set forth in the Food and Drugs Act and the Medical Devices Regulations.

This framework includes licensing (importers must have the necessary licenses before bringing healthcare products into the country), product registration (all healthcare products must be registered with Health Canada, ensuring they meet the required health and safety standards), and inspections and compliance (regular inspections and audits of importers and manufacturers are conducted to ensure ongoing compliance with Canadian health regulations).