Services

Leveraging in-depth industry knowledge, we offer strategic consultation services designed to drive growth and optimize performance. Our expert team collaborates closely with you to deliver customized solutions that align with your unique objectives.

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SUPPLEMENTARY SERVICES

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1: REGULATORY AFFAIRS SERVICES

  • Cosmetic notifications
  • Drug submissions
  • Export certificates for Canadian manufacturers
  • Label & advertising review for compliance
  • Medical device applications
  • Natural health product licence applications
  • Pharmacovigilance
  • Product review, regulatory strategy & feasibility
  • Product submissions & government filings
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2. QUALITY ASSURANCE & GMP SERVICES

  • Audit preparation, representation and follow-up
  • Transportation carrier selection and cold chain
  • Drug establishment licensing support
  • ISO 13485 registrar selection, implementation and support
  • Medical device establishment licensing support
  • Ongoing product support (Drug / NHP release)
  • Recalls and complaint management
  • Site Licence support (Natural Health Products)
  • SOP implementation

3. IMPORT/EXPORT ACTIVITIES

  • Obtain FDA and Health Canada (DEL, MDEL, SL)
  • Establishment licensing and Registrations
  • Obtain export certificates for Canadian manufacturers in support of global registrations
  • Facilitate embassy document legalizations/authentications
  • Support transportation carrier selection and cold chain requirements
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Why Choose Us?

Our team specializes in securing regulatory approvals and ensuring quality compliance for healthcare products in the Canadian market. We are committed to delivering comprehensive regulatory and quality strategies that align with Health Canada’s stringent requirements, guiding your product through every stage of its lifecycle with precision and expertise.

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