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Specialized Healthcare Consulting 

Start Smart Business Solutions specializes in guiding pharmaceutical and life science companies through the intricate regulatory requirements in Canada. Our team of experienced consultants ensures that your business complies with Health Canada's regulations and standards for prescription drugs, OTC products, natural health products, and medical devices. We focus on streamlining product development, ensuring market readiness, and helping you gain market entry.

Prescription Drugs Licensing Consultation & Application

The Prescription Drugs Licensing and Consultation service assists Canadian pharmaceutical companies with navigating complex licensing requirements, ensuring compliance with Health Canada and Canadian Food Inspection Agency regulations. Initially, the service focuses on cosmetics, ensuring products are safe, properly labeled, and manufactured under sanitary conditions. Navigating the complexities of Health Canada's drug licensing process can be overwhelming. Our experts assist in every step of the process, including:

  • Formula development

  • Clinical trial applications (CTAs) consulting

  • International trade certification (ITC)

  • Health claims substantiation

  • Pre-clinical trials assistance

  • New drug submission (NDS) application

  • Ongoing drug testing and maintenance

  • ​Advertisement and marketing compliance

Insurance Consultation
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Over The Counter Drugs Licensing Consultation & Application

The OTC Drugs Licensing Consultation and Application service helps manufacturers, importers, and distributors obtain the necessary Health Canada certifications to distribute OTC drugs, navigating complex regulations and ensuring products meet safety standards before market entry. We provide comprehensive services to ensure your OTC product meets the following:

  • Drug Identification Number (DIN) registration

  • Plain language labelling compliance

  • Health Canada pre-submission meetings

  • ​Establishment License (EL) registration

Natural Health Products Licensing & Consultation

The NHP Licensing and Consultation service helps manufacturers, importers, packagers, and distributors obtain the necessary Health Canada certifications, including the Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), to distribute natural health products in Canada. Start Smart Business Solutions offers a comprehensive range of services to guide clients from product development to market entry. Our services include:

  • Formula development

  • NPN license registration

  • New ingredient submissions via NHPID

  • French translation of product labels

  • NHP Master File submission

  • Health claims substantiation

  • Advertisement and marketing compliance

  • International trade certificate (ITC)

  • ​Site licensing and clinical trials application.

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Medical Device Licensing Consultation & Application

The Medical Device Licensing Consultation and Application service helps Canadian businesses navigate the process of obtaining the required Medical Device Establishment License (MDEL) for distributing, importing, or manufacturing medical devices in Canada. The service ensures clients acquire the appropriate MDEL class based on the device's risk level. Our services include:

  • License class determination and registration

  • MDEL registration

  • In-vitro diagnostic devices registration

  • ​SaMD (Software as a Medical Device) classification and registration.

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